Publications by authors named "David J Beard"

67 Publications

Patient-Reported Function and Quality of Life After Revision Total Knee Arthroplasty: An Analysis of 10,727 Patients from the NHS PROMs Program.

J Arthroplasty 2021 Mar 19. Epub 2021 Mar 19.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK; Nuffield Orthopaedic Centre, Oxford, UK.

Background: The aim of the study was to investigate changes in patient-reported outcome measures (PROMs) after revision total knee arthroplasty (rTKA).

Methods: A total of 10,727 patients undergoing elective rTKA were recruited from the UK National Health Service PROMs data set from 2013 to 2019. PROMs were collected at baseline and six months to assess joint function (Oxford Knee Score, OKS) and quality of life (EQ-5D). Associations with a change in the OKS (COKS) were investigated through multiple linear regression.

Results: The mean COKS was 12.4 (standard deviation 10.7) points. A total of 6776 of 10,329 (65.6%) patients demonstrated increase in the OKS above the minimal important change of 7.5 points. The median change in the EQ-5D utility was 0.227 (interquartile range 0.000 to 0.554). A total of 4917 of 9279 (53.0%) patients achieved a composite endpoint of improvement greater than the minimal important change for joint function and 'better' QoL as per the Paretian analysis. A total of 7477 of 10,727 (69.7%) patients reported satisfaction with rTKA. A total of 7947 of 10,727 (74.1%) patients felt surgery was a success. A total of 4888 of 10,632 (46.0%) patients reported one or more adverse events. A higher preoperative OKS was associated with a lower COKS (coefficient -0.63 [95% confidence interval -0.67 to -0.60]). Other factors associated with a lower COKS were postoperative complication(s), age under 60 years, longer duration of knee problems, patients who identified as disabled, problems in EQ-5D dimensions of anxiety/depression and self-care, comorbid conditions (circulatory problems, diabetes, and depression), and earlier year of procedure in the data set.

Conclusion: Two-thirds of patients experienced a meaningful improvement in joint function after rTKA. However, there was a high frequency of patient-reported complications. These findings may enable better informed discussion of the risks and benefits of discretionary rTKA.
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http://dx.doi.org/10.1016/j.arth.2021.03.037DOI Listing
March 2021

Evidence for the validity of a patient-based instrument for assessment of outcome after revision knee arthroplasty.

Bone Joint J 2021 Apr;103-B(4):627-634

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, UK.

Aims: To estimate the measurement properties for the Oxford Knee Score (OKS) in patients undergoing revision knee arthroplasty (responsiveness, minimal detectable change (MDC-90), minimal important change (MIC), minimal important difference (MID), internal consistency, construct validity, and interpretability).

Methods: Secondary data analysis was performed for 10,727 patients undergoing revision knee arthroplasty between 2013 to 2019 using a UK national patient-reported outcome measure (PROM) dataset. Outcome data were collected before revision and at six months postoperatively, using the OKS and EuroQol five-dimension score (EQ-5D). Measurement properties were assessed according to COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) guidelines.

Results: A total of 9,219 patients had complete outcome data. Mean preoperative OKS was 16.7 points (SD 8.1), mean postoperative OKS 29.1 (SD 11.4), and mean change in OKS + 12.5 (SD 10.7). Median preoperative EQ-5D index was 0.260 (interquartile range (IQR) 0.055 to 0.691), median postoperative EQ-5D index 0.691 (IQR 0.516 to 0.796), and median change in EQ-5D index + 0.240 (IQR 0.000 to 0.567). Internal consistency was good with Cronbach's α 0.88 (baseline) and 0.94 (post-revision). Construct validity found a high correlation of OKS total score with EQ-5D index ( = 0.76 (baseline), = 0.83 (post-revision), p < 0.001). The OKS was responsive with standardized effect size (SES) 1.54 (95% confidence interval (CI) 1.51 to 1.57), compared to SES 0.83 (0.81 to 0.86) for the EQ-5D index. The MIC for the OKS was 7.5 points (95% CI 5.5 to 8.5) based on the optimal cut-off with specificity 0.72, sensitivity 0.60, and area under the curve 0.66. The MID for the OKS was 5.2 points. The MDC-90 was 3.9 points. The OKS did not demonstrate significant floor or ceiling effects.

Conclusion: This study found that the OKS was a useful and valid instrument for assessment of outcome following revision knee arthroplasty. The OKS was responsive to change and demonstrated good measurement properties. Cite this article:  2021;103-B(4):627-634.
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http://dx.doi.org/10.1302/0301-620X.103B4.BJJ-2020-1560.R1DOI Listing
April 2021

Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT.

Health Technol Assess 2020 11;24(65):1-116

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Background: Over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15-30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes.

Objectives: To compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty.

Design: An individually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study.

Setting: The trial took place in 14 NHS physiotherapy departments.

Participants: People identified as being at high risk of a poor outcome after knee arthroplasty.

Interventions: A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy.

Main Outcome Measures: The primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function); Knee injury and Osteoarthritis Outcome Score; Quality of Life subscale; Physical Activity Scale for the Elderly; EuroQol-5 Dimensions, five-level version; and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries.

Results: In total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4-7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2-6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval -0.89 to 1.88 points;  = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold.

Limitations: The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded.

Conclusions: This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it.

Trial Registration: Current Controlled Trials ISRCTN13517704.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 65. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24650DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7750865PMC
November 2020

Targeting rehabilitation to improve outcomes after total knee arthroplasty in patients at risk of poor outcomes: randomised controlled trial.

BMJ 2020 10 13;371:m3576. Epub 2020 Oct 13.

Department of Orthopaedics and Trauma, University of Edinburgh, Edinburgh EH16 4SB, UK.

Objective: To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home exercise based intervention when targeted at patients with a predicted poor outcome after total knee arthroplasty.

Design: Parallel group randomised controlled trial.

Setting: 13 secondary and tertiary care centres in the UK providing postoperative physiotherapy.

Participants: 334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively. 163 were allocated to therapist led outpatient rehabilitation and 171 to a home exercise based protocol.

Interventions: All participants were reviewed by a physiotherapist and commenced 18 sessions of rehabilitation over six weeks, either as therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist).

Main Outcome Measures: Primary outcome was Oxford knee score at 52 weeks, with a 4 point difference between groups considered to be clinically meaningful. Secondary outcomes included additional patient reported outcome measures of pain and function at 14, 26, and 52 weeks post-surgery.

Results: 334 patients were randomised. Eight were lost to follow-up. Intervention compliance was more than 85%. The between group difference in Oxford knee score at 52 weeks was 1.91 (95% confidence interval -0.18 to 3.99) points, favouring the outpatient rehabilitation arm (P=0.07). When all time point data were analysed, the between group difference in Oxford knee score was a non-clinically meaningful 2.25 points (0.61 to 3.90, P=0.01). No between group differences were found for secondary outcomes of average pain (0.25 points, -0.78 to 0.28, P=0.36) or worst pain (0.22 points, -0.71 to 0.41, P=0.50) at 52 weeks or earlier time points, or of satisfaction with outcome (odds ratio 1.07, 95% confidence interval 0.71 to 1.62, P=0.75) or post-intervention function (4.64 seconds, 95% confidence interval -14.25 to 4.96, P=0.34).

Conclusions: Outpatient therapist led rehabilitation was not superior to a single physiotherapist review and home exercise based regimen in patients at risk of poor outcomes after total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures.

Trials Registration: Current Controlled Trials ISRCTN23357609 and ClinicalTrials.gov NCT01849445.
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http://dx.doi.org/10.1136/bmj.m3576DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551789PMC
October 2020

Further reflections on TOPKAT and Partial . Total Knee Replacement-response to authors.

Ann Transl Med 2020 Jun;8(11):730

Health Services Research Unit, Health Sciences Building, University of Aberdeen, Aberdeen, UK.

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http://dx.doi.org/10.21037/atm-2020-59DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7327336PMC
June 2020

The use of patient-reported outcome measures to guide referral for hip and knee arthroplasty.

Bone Joint J 2020 Jul;102-B(7):941-949

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK.

Aims: To calculate how the likelihood of obtaining measurable benefit from hip or knee arthroplasty varies with preoperative patient-reported scores.

Methods: Existing UK data from 222,933 knee and 209,760 hip arthroplasty patients were used to model an individual's probability of gaining meaningful improvement after surgery based on their preoperative Oxford Knee or Hip Score (OKS/OHS). A clinically meaningful improvement after arthroplasty was defined as ≥ 8 point improvement in OHS, and ≥ 7 in OKS.

Results: The upper preoperative score threshold, above which patients are unlikely to achieve any meaningful improvement from surgery, is 41 for knees and 40 for hips. At lower scores, the probability of improvement increased towards a maximum of 88% (knee) and 95% for (hips).

Conclusion: By our definition of meaningful improvement, patients with preoperative scores above 41 (OKS) and 40 (OHS) should not be routinely referred to secondary care for possible arthroplasty. Using lower thresholds would incrementally increase the probability of meaningful benefit for those referred but will exclude some patients with potential to benefit. The findings are useful to support the complex shared decision-making process in primary care for referral to secondary care; and in secondary care for experienced clinicians counselling patients considering knee or hip arthroplasty, but should not be used in isolation. Cite this article: 2020;102-B(7):941-949.
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http://dx.doi.org/10.1302/0301-620X.102B7.BJJ-2019-0102.R2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376303PMC
July 2020

Manipulation Under Anesthetic After Primary Knee Arthroplasty Is Associated With a Higher Rate of Subsequent Revision Surgery.

J Arthroplasty 2020 09 11;35(9):2640-2645.e2. Epub 2020 Apr 11.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; NIHR Biomedical Research Unit, University of Oxford, Oxford, UK; Nuffield Orthopaedic Centre, Oxford, UK.

Aim: To determine the association between manipulation under anesthetic (MUA) after primary knee arthroplasty and subsequent revision surgery.

Methods: Patients undergoing primary knee arthroplasty from April 2011 to April 2016 with minimum 1-year follow-up to April 2017 were identified from the national hospital episode statistics for England. The first arthroplasty per patient, per side, was included; cases with a record of subsequent infection or periprosthetic fracture were excluded. Patients undergoing MUA within 1 year to the same knee were identified, defining the populations for the MUA and non-MUA cohorts. Mortality-adjusted Kaplan-Meier survival analysis (revision arthroplasty) was performed to a maximum of 6 years. A Cox proportional hazards model was used to determine the hazard for revision, adjusting for type of primary arthroplasty, gender, age group, year, comorbidity index, obesity, regional deprivation, rurality, and ethnicity.

Results: A total of 309,650 primary arthroplasty cases (309,650 patients) were included. MUA within 1 year was recorded in 6882 patients (2.22%; 95% confidence interval [95% CI], 2.17-2.28) defining the MUA cohort; all others were included in the parallel non-MUA cohort. At 6 years, the mortality-adjusted estimated implant survival rate in the MUA cohort was 91.2% (95% CI, 90.0-92.2) in comparison to 98.1% (95% CI, 98.0-98.2) in the non-MUA cohort. In the fully adjusted model, this corresponded to an adjusted hazard for revision of 5.03 (hazard ratio; 95% CI, 4.55-5.57).

Conclusion: Patients who underwent MUA within 1 year of primary arthroplasty were at a 5-fold increased risk of subsequent revision even after excluding cases of infection or fracture. Further investigation of the etiology of stiffness after primary knee arthroplasty and the optimal treatment options to improve outcomes is justified.
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http://dx.doi.org/10.1016/j.arth.2020.04.015DOI Listing
September 2020

Total versus partial knee replacement in patients with medial compartment knee osteoarthritis: the TOPKAT RCT.

Health Technol Assess 2020 04;24(20):1-98

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Background: Late-stage medial compartment knee osteoarthritis can be treated using total knee replacement or partial (unicompartmental) knee replacement. There is high variation in treatment choice and insufficient evidence to guide selection.

Objective: To assess the clinical effectiveness and cost-effectiveness of partial knee replacement compared with total knee replacement in patients with medial compartment knee osteoarthritis. The findings are intended to guide surgical decision-making for patients, surgeons and health-care providers.

Design: This was a randomised, multicentre, pragmatic comparative effectiveness trial that included an expertise component. The target sample size was 500 patients. A web-based randomisation system was used to allocate treatments.

Setting: Twenty-seven NHS hospitals (68 surgeons).

Participants: Patients with medial compartment knee osteoarthritis.

Interventions: The trial compared the overall management strategy of partial knee replacement treatment with total knee replacement treatment. No specified brand or subtype of implant was investigated.

Main Outcome Measures: The Oxford Knee Score at 5 years was the primary end point. Secondary outcomes included activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite 'failure' - defined by minimal Oxford Knee Score improvement and/or reoperation). Cost-effectiveness was also assessed.

Results: A total of 528 patients were randomised (partial knee replacement,  = 264; total knee replacement,  = 264). The follow-up primary outcome response rate at 5 years was 88% and both operations had good outcomes. There was no significant difference between groups in mean Oxford Knee Score at 5 years (difference 1.04, 95% confidence interval -0.42 to 2.50). An area under the curve analysis of the Oxford Knee Score at 5 years showed benefit in favour of partial knee replacement over total knee replacement, but the difference was within the minimal clinically important difference [mean 36.6 (standard deviation 8.3) ( = 233), mean 35.1 (standard deviation 9.1) ( = 231), respectively]. Secondary outcome measures showed consistent patterns of benefit in the direction of partial knee replacement compared with total knee replacement although most differences were small and non-significant. Patient-reported improvement (transition) and reflection (would you have the operation again?) showed statistically significant superiority for partial knee replacement only, but both of these variables could be influenced by the lack of blinding. The frequency of reoperation (including revision) by treatment received was similar for both groups: 22 out of 245 for partial knee replacement and 28 out of 269 for total knee replacement patients. Revision rates at 5 years were 10 out of 245 for partial knee replacement and 8 out of 269 for total knee replacement. There were 28 'failures' of partial knee replacement and 38 'failures' of total knee replacement (as defined by composite outcome). Beyond 1 year, partial knee replacement was cost-effective compared with total knee replacement, being associated with greater health benefits (measured using quality-adjusted life-years) and lower health-care costs, reflecting lower costs of the index surgery and subsequent health-care use.

Limitations: It was not possible to blind patients in this study and there was some non-compliance with the allocated treatment interventions. Surgeons providing partial knee replacement were relatively experienced with the procedure.

Conclusions: Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates. Some patient-reported measures of treatment approval were significantly higher for partial knee replacement than for total knee replacement. Partial knee replacement was more cost-effective (more effective and cost saving) than total knee replacement at 5 years.

Future Work: Further (10-year) follow-up is in progress to assess the longer-term stability of these findings.

Trial Registration: Current Controlled Trials ISRCTN03013488 and ClinicalTrials.gov NCT01352247.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 20. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24200DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7232134PMC
April 2020

Rates of knee arthroplasty in patients with a history of arthroscopic chondroplasty: results from a retrospective cohort study utilising the National Hospital Episode Statistics for England.

BMJ Open 2020 04 16;10(4):e030609. Epub 2020 Apr 16.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Objective: The purpose of this study was to analyse the rate of knee arthroplasty in the population of patients with a history of arthroscopic chondroplasty of the knee, in England, over 10 years, with comparison to general population data for patients without a history of chondroplasty.

Design: Retrospective cohort study.

Setting: English Hospital Episode Statistics (HES) data.

Participants And Interventions: Patients undergoing arthroscopic chondroplasty in England between 2007/2008 and 2016/2017 were identified. Patients undergoing previous arthroscopic knee surgery or simultaneous cruciate ligament reconstruction or microfracture in the same knee were excluded.

Outcomes: Patients subsequently undergoing a knee arthroplasty in the same knee were identified and mortality-adjusted survival analysis was performed (survival without undergoing knee arthroplasty). A Cox proportional hazards model was used to identify factors associated with knee arthroplasty. Relative risk of knee arthroplasty (total or partial) in comparison to the general population was determined.

Results: Through 2007 to 2017, 157 730 eligible chondroplasty patients were identified. Within 1 year, 5.91% (7984/135 197; 95% CI 5.78 to 6.03) underwent knee arthroplasty and 14.22% (8145/57 267; 95% CI 13.94 to 14.51) within 5 years. Patients aged over 30 years with a history of chondroplasty were 17.32 times (risk ratio; 95% CI 16.81 to 17.84) more likely to undergo arthroplasty than the general population without a history of chondroplasty.

Conclusions: Patients with cartilage lesions of the knee, treated with arthroscopic chondroplasty, are at greater risk of subsequent knee arthroplasty than the general population and for a proportion of patients, there is insufficient benefit to prevent the need for knee arthroplasty within 1 to 5 years. These important new data will inform patients of the anticipated outcomes following this procedure. The risk in comparison to non-operative treatment remains unknown and there is an urgent need for a randomised clinical trial in this population.
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http://dx.doi.org/10.1136/bmjopen-2019-030609DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7200031PMC
April 2020

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).

Lancet 2020 03;395(10226):828-838

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.
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http://dx.doi.org/10.1016/S0140-6736(19)33137-XDOI Listing
March 2020

Varus alignment of the proximal tibia is associated with structural progression in early to moderate varus osteoarthritis of the knee.

Knee Surg Sports Traumatol Arthrosc 2020 Oct 21;28(10):3279-3286. Epub 2020 Jan 21.

Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Old Rd, Oxford, OX3 7LD, UK.

Purpose: Lower limb malalignment is a strong predictor of progression in knee osteoarthritis. The purpose of this study is to identify the individual alignment variables that predict progression in early to moderate osteoarthritis of the knee.

Method: A longitudinal cohort study using data from the Osteoarthritis Initiative. In total, 955 individuals (1329 knees) with early to moderate osteoarthritis (Kellgren-Lawrence grade 1, 2 or 3) were identified. All subjects had full-limb radiographs analysed using the Osteotomy module within Medicad Classic (Hectec GMBH) to give a series of individual alignment variables relevant to the coronal alignment of the lower limb. Logistic regression models, with generalised estimating equations were used to identify which of these individual alignment variables predict symptom worsening (WOMAC score > 9 points) and or structural progression (joint space narrowing progression in the medial compartment > 0.7mm) over 24 months.

Results: Individual alignment variable were associated with both valgus and varus alignment (mechanical Lateral Distal Femoral Angle, Medial Proximal Tibial Angle and mechanical Lateral Distal Tibial Angle). Only the Medial Proximal Tibial Angle was significantly associated with structural progression and none of the variables was associated with symptom progression. The odds of joint space narrowing progression in the medial compartment occurring at 24 months increased by 21% for every one degree decrease (more varus) in Medial Proximal Tibial Angle (p < 0.001) CONCLUSIONS: Our results suggest that the risk of structural progression in the medial compartment is associated with greater varus alignment of the proximal tibia.

Level Of Evidence: Level III, retrospective cohort study.
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http://dx.doi.org/10.1007/s00167-019-05840-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7511471PMC
October 2020

Mortality and adverse joint outcomes following septic arthritis of the native knee: a longitudinal cohort study of patients receiving arthroscopic washout.

Lancet Infect Dis 2020 03 17;20(3):341-349. Epub 2019 Dec 17.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK; National Institute for Health Research (NIHR) Biomedical Research Centre, Oxford, UK.

Background: The short-term and long-term consequences of septic arthritis are uncertain. We aimed to determine risk of mortality and adverse joint outcomes following septic arthritis of the native knee.

Methods: We did a retrospective cohort study in patients who received arthroscopic knee washout for septic arthritis in England between April 1, 1997, and March 31, 2017, using data in the national Hospital Episode Statistics database. Patients with previous knee surgery to the same knee were excluded. Mortality within 90 days, adverse joint outcomes (arthrodesis, amputation, arthroplasty) within 1 year, and arthroplasty within 15 years were determined. Mortality in patients with a primary admitting diagnosis of septic arthritis (ICD-10) was compared with that in patients in whom septic arthritis was a secondary diagnosis.

Findings: 12 132 patients were included (mean age 56·6 years [SD 24·9]) of whom 4307 (36%) were female. In 10 195 (84%) patients with septic arthritis as the primary admitting diagnosis, 90-day mortality was 7·05% (95% CI 6·56-7·57; 719 patients), rising to 22·69% (20·80-24·68; 418 patients) in 1842 patients older than 79 years. Secondary septic arthritis diagnosis versus primary diagnosis was associated with an adjusted odds ratio for mortality of 2·10 (95% CI 1·79-2·46; p<0·0001). In 11 393 patients with at least 1 year follow-up, the 1 year rates were 0·13% (95% CI 0·07-0·22; 15 patients) for arthrodesis, 0·40% (0·30-0·54; 46 patients) for amputation, and 1·33%; (1·13-1·56; 152 patients) for arthroplasty. Within 15 years, 159 (8·76%; 95% CI 7·50-10·15) of 1816 patients had received arthroplasty, corresponding to an annual risk of arthroplasty that was about six times that of the general population (risk ratio 6·14, 95% CI 4·95-7·62; p<0·0001).

Interpretation: The consequences of septic knee arthritis in patients undergoing arthroscopic knee washout are serious. These findings highlight the potentially devastating outcomes associated with sepsis from musculoskeletal joint infection.

Funding: National Institute for Health Research.
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http://dx.doi.org/10.1016/S1473-3099(19)30419-0DOI Listing
March 2020

Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review.

J Clin Epidemiol 2020 03 28;119:109-116. Epub 2019 Nov 28.

National Institute of Health Research (NIHR), Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol, Surgical Innovation theme and the Medical Research Council ConDuCT-II Hub for Trials Methodology Research, Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol, UK; Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.

Objectives: To examine key methodological considerations for using a placebo intervention in randomized controlled trials (RCTs) evaluating invasive procedures, including surgery.

Study Design And Setting: RCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to December 31, 2017, were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, by handsearching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centers) and key methodological (rationale for using placebos, minimization of risk, information provision, offering the treatment intervention to patients randomized to placebo, delivery of cointerventions, and intervention standardization and fidelity) were extracted and summarized descriptively.

Results: One hundred thirteen articles reporting 96 RCTs were identified. Most were conducted in gastrointestinal surgery (n = 40, 42%) and evaluated minimally invasive procedures (n = 44, 46%). Over two-thirds randomized fewer than 100 patients (n = 65, 68%) and a third were single center (n = 31, 32%). A third (n = 33, 34%) did not report a rationale for using a placebo. Most common strategies to minimize patient risk were operator skill (n = 22, 23%) and independent data monitoring (n = 28, 29%). Provision of patient information regarding placebo use was infrequently reported (n = 11, 11%). Treatment interventions were offered to patients randomized to placebo in 43 trials (45%). Cointerventions were inconsistently reported, but 64 trials (67%) stated that anesthesia was matched between groups. Attempts to standardize interventions and monitor their delivery were reported in n = 7, (7%) and n = 4, (4%) trials, respectively.

Conclusion: Most placebo-controlled trials in surgery evaluate minor surgical procedures and currently there is inconsistent reporting of key trial methods. There is a need for guidance to optimize the transparency of trial reporting in this area.
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http://dx.doi.org/10.1016/j.jclinepi.2019.11.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066579PMC
March 2020

Long-term rates of knee arthroplasty in a cohort of 834 393 patients with a history of arthroscopic partial meniscectomy.

Bone Joint J 2019 Sep;101-B(9):1071-1080

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Aims: The aim of this study was to determine the long-term risk of undergoing knee arthroplasty in a cohort of patients with meniscal tears who had undergone arthroscopic partial meniscectomy (APM).

Patients And Methods: A retrospective national cohort of patients with a history of isolated APM was identified over a 20-year period. Patients with prior surgery to the same knee were excluded. The primary outcome was knee arthroplasty. Hazard ratios (HRs) were adjusted by patient age, sex, year of APM, Charlson comorbidity index, regional deprivation, rurality, and ethnicity. Risk of arthroplasty in the index knee was compared with the patient's contralateral knee (with without a history of APM). A total of 834 393 patients were included (mean age 50 years; 37% female).

Results: Of those with at least 15 years of follow-up, 13.49% (16 256/120 493; 95% confidence interval (CI) 13.30 to 13.69) underwent subsequent arthroplasty within this time. In women, 22.07% (95% CI 21.64 to 22.51) underwent arthroplasty within 15 years compared with 9.91% of men (95% CI 9.71 to 10.12), corresponding to a risk ratio (RR) of 2.23 (95% CI 2.16 to 2.29). Relative to the general population, patients with a history of APM were over ten times more likely (RR 10.27; 95% CI 10.07 to 10.47) to undergo arthroplasty rising to almost 40 times more likely (RR 39.62; 95% CI 27.68 to 56.70) at a younger age (30 to 39 years). In patients with a history of APM in only one knee, the risk of arthroplasty in that knee was greatly elevated in comparison with the contralateral knee (no APM; HR 2.99; 95% CI 2.95 to 3.02).

Conclusion: Patients developing a meniscal tear undergoing APM are at greater risk of knee arthroplasty than the general population. This risk is three-times greater in the patient's affected knee than in the contralateral knee. Women in the cohort were at double the risk of progressing to knee arthroplasty compared with men. These important new reference data will inform shared decision making and enhance approaches to treatment, prevention, and clinical surveillance. Cite this article: 2019;101-B:1071-1080.
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http://dx.doi.org/10.1302/0301-620X.101B9.BJJ-2019-0335.R1DOI Listing
September 2019

Rates of Adverse Outcomes and Revision Surgery After Anterior Cruciate Ligament Reconstruction: A Study of 104,255 Procedures Using the National Hospital Episode Statistics Database for England, UK.

Am J Sports Med 2019 09 26;47(11):2533-2542. Epub 2019 Jul 26.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Background: After an anterior cruciate ligament (ACL) injury, ACL reconstruction is an elective procedure, and therefore, an understanding of the attributable risk from undergoing ACL reconstruction is necessary for patients to make a fully informed treatment decision.

Purpose: To determine the absolute risk of adverse outcomes including reoperation after ACL reconstruction with comparison, where possible, to the rate of adverse events reported in the general population.

Study Design: Descriptive epidemiology study.

Methods: National hospital data on all ACL reconstructions performed in England between April 1, 1997, and March 31, 2017, were analyzed. Revision cases, bilateral procedures within 6 months, and cases with concurrent cartilage or multiple ligament surgery were excluded. The primary outcome was the occurrence of at least 1 serious complication (myocardial infarction, stroke, pulmonary embolism, infection requiring surgery, fasciotomy, neurovascular injury, or death) within 90 days. Additionally, 5-year rates of revision ACL reconstruction, contralateral ACL reconstruction, and meniscal surgery were investigated.

Results: There were 133,270 ACL reconstructions performed, of which 104,255 were eligible for analysis. Within 90 days, serious complications occurred in 675 (0.65% [95% CI, 0.60-0.70]), including 494 reoperations for infections (0.47% [95% CI, 0.43-0.52]) and 129 for pulmonary embolism (0.12% [95% CI, 0.10-0.15]). Of 54,275 procedures with at least 5 years' follow-up, 1746 (3.22% [95% CI, 3.07-3.37]) underwent revision ACL reconstruction in the same knee, 1553 underwent contralateral ACL reconstruction (2.86% [95% CI, 2.72-3.01]), and 340 underwent meniscal surgery (0.63% [95% CI, 0.56-0.70]). The overall risk of serious complications fell over time (adjusted odds ratio [OR], 0.96 per year [95% CI, 0.95-0.98]); however, older patients (adjusted OR, 1.11 per 5 years [95% CI, 1.07-1.16]) and patients with a greater modified Charlson Comorbidity Index (adjusted OR, 2.41 per 10 units [95% CI, 1.65-3.51]) were at a higher risk. For every 850 (95% CI, 720-1039) ACL reconstructions, 1 pulmonary embolism could be provoked. For every 213 (95% CI, 195-233), 1 native knee joint infection could be provoked.

Conclusion: The overall risk of adverse events after ACL reconstruction is low; however, some rare but serious complications, including infections or pulmonary embolism, may occur. Around 3% of patients undergo further ipsilateral or contralateral ACL reconstruction within 5 years. These data will inform shared decision making between clinicians and patients considering their treatment options.
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http://dx.doi.org/10.1177/0363546519861393DOI Listing
September 2019

The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial.

Lancet 2019 08 17;394(10200):746-756. Epub 2019 Jul 17.

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Background: Late-stage isolated medial knee osteoarthritis can be treated with total knee replacement (TKR) or partial knee replacement (PKR). There is high variation in treatment choice and little robust evidence to guide selection. The Total or Partial Knee Arthroplasty Trial (TOPKAT) therefore aims to assess the clinical effectiveness and cost-effectiveness of TKR versus PKR in patients with medial compartment osteoarthritis of the knee, and this represents an analysis of the main endpoints at 5 years.

Methods: Our multicentre, pragmatic randomised controlled trial was done at 27 UK sites. We used a combined expertise-based and equipoise-based approach, in which patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR were randomly assigned (1:1) to receive PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure. The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups. Health-care costs (in UK 2017 prices) and cost-effectiveness were also assessed. This trial is registered with ISRCTN (ISRCTN03013488) and ClinicalTrials.gov (NCT01352247).

Findings: Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45%) patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients were randomly assigned to groups. 94% of participants responded to the follow-up survey 5 years after their operation. At the 5-year follow-up, we found no difference in OKS between groups (mean difference 1·04, 95% CI -0·42 to 2·50; p=0·159). In our within-trial cost-effectiveness analysis, we found that PKR was more effective (0·240 additional quality-adjusted life-years, 95% CI 0·046 to 0·434) and less expensive (-£910, 95% CI -1503 to -317) than TKR during the 5 years of follow-up. This finding was a result of slightly better outcomes, lower costs of surgery, and lower follow-up health-care costs with PKR than TKR.

Interpretation: Both TKR and PKR are effective, offer similar clinical outcomes, and result in a similar incidence of re-operations and complications. Based on our clinical findings, and results regarding the lower costs and better cost-effectiveness with PKR during the 5-year study period, we suggest that PKR should be considered the first choice for patients with late-stage isolated medial compartment osteoarthritis.

Funding: National Institute for Health Research Health Technology Assessment Programme.
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http://dx.doi.org/10.1016/S0140-6736(19)31281-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6727069PMC
August 2019

Surgical interventions for symptomatic mild to moderate knee osteoarthritis.

Cochrane Database Syst Rev 2019 07 19;7:CD012128. Epub 2019 Jul 19.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road, Headington, Oxford, UK, OX3 7LD.

Background: Osteoarthritis affecting the knee is common and represents a continuum of disease from early cartilage thinning to full-thickness cartilage loss, bony erosion, and deformity. Many studies do not stratify their results based on the severity of the disease at baseline or recruitment.

Objectives: To assess the benefits and harms of surgical intervention for the management of symptomatic mild to moderate knee osteoarthritis defined as knee pain and radiographic evidence of non-end stage osteoarthritis (Kellgren-Lawrence grade 1, 2, 3 or equivalent on MRI/arthroscopy). Outcomes of interest included pain, function, radiographic progression, quality of life, short-term serious adverse events, re-operation rates and withdrawals due to adverse events.

Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase up to May 2018. We also conducted searches of ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for ongoing trials. Authors of trials were contacted if some but not all their participants appeared to fit our inclusion criteria.

Selection Criteria: We included randomised controlled trials that compared surgery to non-surgical interventions (including sham and placebo control groups, exercise or physiotherapy, and analgesic or other medication), injectable therapies, and trials that compared one type of surgical intervention to another surgical intervention in people with symptomatic mild to moderate knee osteoarthritis.

Data Collection And Analysis: Two review authors independently selected trials and extracted data using standardised forms. We analysed the quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.

Main Results: A total of five studies involving 566 participants were identified as eligible for this review. Single studies compared arthroscopic partial meniscectomy to physical therapy (320 participants), arthroscopic surgery (debridement ± synovectomy ± chondroplasty) to closed needle joint lavage with saline (32 participants) and high tibial osteotomy surgery to knee joint distraction surgery (62 participants). Two studies (152 participants) compared arthroscopic surgery (washout ± debridement; debridement) to a hyaluronic acid injection. Only one study was at low risk of selection bias, and due to the difficulty of blinding participants to their treatment, all studies were at risk of performance and detection bias.Reporting of results in this summary has been restricted to the primary comparison: surgical intervention versus non-surgical intervention.A single study, included 320 participants with symptoms consistent with meniscal tear. All subjects had the meniscal tear confirmed on knee MRI and radiographic evidence of mild to moderate osteoarthritis (osteophytes, cartilage defect or joint space narrowing). Patients with severe osteoarthritis (KL grade 4) were excluded. The study compared arthroscopic partial meniscectomy and physical therapy to physical therapy alone (a six-week individualised progressive home exercise program). This study was at low risk of selection bias and outcome reporting biases, but was susceptible to performance and detection biases. A high rate of cross-over (30.2%) occurred from the physical therapy group to the arthroscopic group.Low-quality evidence suggests there may be little difference in pain and function at 12 months follow-up in people who have arthroscopic partial meniscectomy and those who have physical therapy. Evidence was downgraded to low quality due to risk of bias and imprecision.Mean pain was 19.3 points on a 0 to 100 point KOOS pain scale with physical therapy at 12 months follow-up and was 0.2 points better with surgery (95% confidence interval (CI) 4.05 better to 3.65 points worse with surgery, an absolute improvement of 0.2% (95% CI 4% better to 4% worse) and relative improvement 0.4% (95% CI 9% better to 8% worse) (low quality evidence). Mean function was 14.5 on a 0 to 100 point KOOS function scale with physical therapy at 12 months follow-up and 0.8 points better with surgery (95% CI 4.3 better to 2.7 worse); 0.8% absolute improvement (95% CI 4% better to 3% worse) and 2.1% relative improvement (95% CI 11% better to 7% worse) (low quality evidence).Radiographic structural osteoarthritis progression and quality of life outcomes were not reported.Due to very low quality evidence, we are uncertain if surgery is associated with an increased risk of serious adverse events, incidence of total knee replacement or withdrawal rates. Evidence was downgraded twice due to very low event rates, and once for risk of bias.At 12 months, the surgery group had a total of three serious adverse events including fatal pulmonary embolism, myocardial infarction and hypoxaemia. The physical therapy alone group had two serious adverse events including sudden death and stroke (Peto OR 1.58, 95% CI 0.27 to 9.21); 1% more events with surgery (95% CI 2% less to 3% more) and 58% relative change (95% CI 73% less to 821% more). One participant in each group withdrew due to adverse events.Two of 164 participants (1.2%) in the physical therapy group and three of 156 in the surgery group underwent conversion to total knee replacement within 12 months (Peto OR 1.76, 95% CI 0.43 to 7.13); 1% more events with surgery (95% CI 2% less to 5% more); 76% relative change (95% CI 57% less to 613% more).

Authors' Conclusions: The review found no placebo-or sham-controlled trials of surgery in participants with symptomatic mild to moderate knee osteoarthritis. There was low quality evidence that there may be no evidence of a difference between arthroscopic partial meniscectomy surgery and a home exercise program for the treatment of this condition. Similarly, low-quality evidence from a few small trials indicates there may not be any benefit of arthroscopic surgery over other non-surgical treatments including saline irrigation and hyaluronic acid injection, or one type of surgery over another. We are uncertain of the risk of adverse events or of progressing to total knee replacement due to very small event rates. Thus, there is uncertainty around the current evidence to support or oppose the use of surgery in mild to moderate knee osteoarthritis. As no benefit has been demonstrated from the low quality trials included in this review, it is possible that future higher quality trials for these surgical interventions may not contradict these results.
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http://dx.doi.org/10.1002/14651858.CD012128.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6639936PMC
July 2019

Rates of knee arthroplasty in anterior cruciate ligament reconstructed patients: a longitudinal cohort study of 111,212 procedures over 20 years.

Acta Orthop 2019 12 10;90(6):568-574. Epub 2019 Jul 10.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK.

Background and purpose - Long-term rates of knee arthroplasty in patients with anterior cruciate ligament (ACL) injury who undergo ligament reconstruction (ACLr) are unclear. We determined this risk of arthroplasty through comparison with the general population.Patients and methods - All patients undergoing an ACLr in England, 1997-2017, were identified from national hospital statistics. Patients subsequently undergoing a knee arthroplasty were identified and survival analysis was performed (survival without undergoing knee arthroplasty). A Cox proportional hazards model was used to identify factors associated with knee arthroplasty. Relative risk of knee arthroplasty (total or partial) in comparison with the general population was determined.Results - 111,212 ACLr patients were eligible for analysis (mean age 29; 77% male). Overall, 0.46% (95% confidence interval [CI] 0.40-0.52) ACLr patients underwent knee arthroplasty within 5 years, 0.97% (CI 0.82-1.2) within 10 years, and 1.8% (CI 1.4-2.3) within 15 years. Knee arthroplasty risk was greater in older age groups and women. In comparison with the general population, the relative risk of undergoing arthroplasty at a younger age (at time of arthroplasty) was elevated: at 30-39 years (risk ratio [RR] 20; CI 11-35), 40-49 years (RR 7.5; CI 5.5-10), and 50-59 years (RR 2.5; CI 1.8-3.5), but not 60-69 years (RR 1.7; CI 0.93-3.2).Interpretation - Patients sustaining an ACL injury who undergo ACLr are at elevated risk of subsequent knee arthroplasty in comparison with the general population. Although the absolute rate of arthroplasty is low, the risk of arthroplasty at a younger age is particularly elevated. When the outcome of shared decision-making is ACLr, this data will help inform patients and clinicians about the long-term risk of requiring knee arthroplasty.
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http://dx.doi.org/10.1080/17453674.2019.1639360DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6844427PMC
December 2019

Evidence update: A summary of new evidence to inform treatment decisions for patients with meniscal lesions.

Knee 2019 06 23;26(3):521-523. Epub 2019 May 23.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK; National Institute for Health Research (NIHR), Biomedical Research Centre, Oxford, UK.

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http://dx.doi.org/10.1016/j.knee.2019.04.017DOI Listing
June 2019

Arthroscopic partial meniscectomy for meniscal tears of the knee: a systematic review and meta-analysis.

Br J Sports Med 2020 Jun 22;54(11):652-663. Epub 2019 Feb 22.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Objective: To assess the benefit of arthroscopic partial meniscectomy (APM) in adults with a meniscal tear and knee pain in three defined populations (taking account of the comparison intervention): (A) all patients (any type of meniscal tear with or without radiographic osteoarthritis); (B) patients with any type of meniscal tear in a non-osteoarthritic knee; and (C) patients with an unstable meniscal tear in a non-osteoarthritic knee.

Design: Systematic review and meta-analysis.

Datasources: A search of MEDLINE, Embase, CENTRAL, Scopus, Web of Science, Clinicaltrials.gov and ISRCTN was performed, unlimited by language or publication date (inception to 18 October 2018).

Eligibilitycriteria: Randomised controlled trials performed in adults with meniscal tears, comparing APM versus (1) non-surgical intervention; (2) pharmacological intervention; (3) surgical intervention; and (4) no intervention.

Results: Ten trials were identified: seven compared with non-surgery, one pharmacological and two surgical. Findings were limited by small sample size, small number of trials and cross-over of participants to APM from comparator interventions. In group A (all patients) receiving APM versus non-surgical intervention (physiotherapy), at 6-12 months, there was a small mean improvement in knee pain (standardised mean difference [SMD] 0.22 [95% CI 0.03 to 0.40]; five trials, 943 patients; I 48%; Grading of Recommendations Assessment, Development and Evaluation [GRADE]: low), knee-specific quality of life (SMD 0.43 [95% CI 0.10 to 0.75]; three trials, 350 patients; I 56%; GRADE: low) and knee function (SMD 0.18 [95% CI 0.04 to 0.33]; six trials, 1050 patients; I 27%; GRADE: low). When the analysis was restricted to people without osteoarthritis (group B), there was a small to moderate improvement in knee pain (SMD 0.35 [95% CI 0.04 to 0.66]; three trials, 402 patients; I 58%; GRADE: very low), knee-specific quality of life (SMD 0.59 [95% CI 0.11 to 1.07]; two trials, 244 patients; I 71%; GRADE: low) and knee function (SMD 0.30 [95% CI 0.06 to 0.53]; four trials, 507 patients; I 44%; GRADE: very low). There was no improvement in knee pain, function or quality of life in patients receiving APM compared with placebo surgery at 6-12 months in group A or B (pain: SMD 0.08 [95% CI -0.24 to 0.41]; one trial, 146 patients; GRADE: low; function: SMD -0.08 [95% CI -0.41 to 0.24]; one trial, 146 patients; GRADE: high; quality of life: SMD 0.05 [95% CI -0.27 to 0.38]; one trial; 146 patients; GRADE: high). No trials were identified for people in group C.

Conclusion: Performing APM in all patients with knee pain and a meniscal tear is not appropriate, and surgical treatment should not be considered the first-line intervention. There may, however, be a small-to-moderate benefit from APM compared with physiotherapy for patients without osteoarthritis. No trial has been limited to patients failing non-operative treatment or patients with an unstable meniscal tear in a non-arthritic joint; research is needed to establish the value of APM in this population.

Protocol Registration Number: PROSPERO CRD42017056844.
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http://dx.doi.org/10.1136/bjsports-2018-100223DOI Listing
June 2020

Exploring variation in patient access of post-discharge physiotherapy following total hip and knee arthroplasty under a choice based system in the UK: an observational cohort study.

BMJ Open 2019 02 20;9(2):e021614. Epub 2019 Feb 20.

Department of Orthopaedics and Trauma, University of Edinburgh, Edinburgh, UK.

Objectives: To assess a targeted 'therapy as required' model of post-discharge outpatient physiotherapy provision. Specifically, we investigated what proportion of patients accessed post-discharge physiotherapy following total hip arthroplasty (THA) and total knee arthroplasty (TKA), whether accessing therapy was associated with post-arthroplasty patient reported outcomes and whether it was possible to predict which patients would access post-discharge physiotherapy from pre-operative data.

Design: Prospective, observational, longitudinal cohort study.

Setting: Single National Health Service orthopaedic teaching hospital in the UK.

Participants: 1395 patients undergoing total hip arthroplasty and 1374 patients undergoing total knee arthroplasty.

Primary And Secondary Outcome Measures: Self-reported access of post-discharge physiotherapy, the Oxford Hip or Knee Score, EuroQol 5-dimension questionnaire and post-operative surgical episode satisfaction metric.

Results: 662 (48.2%) patients with TKA and 493 (35.3%) patients with THA accessed additional post-discharge physiotherapy. Patient-reported outcomes (p<0.001) and surgical episode satisfaction (p=0.001) in both THA and TKA were higher in patients that did not participate in post-discharge physiotherapy. Regression models using pre-operative symptom burden and demographic data predicted post-discharge therapy access with an accuracy of only 17% greater than chance in patients with THA and 7% greater than chance in patients with TKA.

Conclusions: In a choice-based service model of 'therapy as required' following hip and knee arthroplasty only a third of THA and half of TKA patients accessed post-discharge therapy. Patients who did not access physiotherapy reported greater post-operative outcomes. This variation in the need for post-discharge physiotherapy suggests that targeting of rehabilitation may be a cost-effective model, however it was not possible to reliably predict which patients would access post-discharge physiotherapy from pre-operative data.
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http://dx.doi.org/10.1136/bmjopen-2018-021614DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6398686PMC
February 2019

Arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of symptomatic femoroacetabular impingement: multicentre randomised controlled trial.

BMJ 2019 02 7;364:l185. Epub 2019 Feb 7.

Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK.

Objective: To compare arthroscopic hip surgery with physiotherapy and activity modification for improving patient reported outcome measures in patients with symptomatic femoroacetabular impingement (FAI).

Design: Two group parallel, assessor blinded, pragmatic randomised controlled trial.

Setting: Secondary and tertiary care centres across seven NHS England sites.

Participants: 222 participants aged 18 to 60 years with symptomatic FAI confirmed clinically and with imaging (radiography or magnetic resonance imaging) were randomised (1:1) to receive arthroscopic hip surgery (n=112) or a programme of physiotherapy and activity modification (n=110). Exclusion criteria included previous surgery, completion of a physiotherapy programme targeting FAI within the preceding 12 months, established osteoarthritis (Kellgren-Lawrence grade ≥2), and hip dysplasia (centre-edge angle <20 degrees).

Interventions: Participants in the physiotherapy group received a goal based programme tailored to individual patient needs, with emphasis on improving core stability and movement control. A maximum of eight physiotherapy sessions were delivered over five months. Participants in the arthroscopic surgery group received surgery to excise the bone that impinged during hip movements, followed by routine postoperative care.

Main Outcome Measures: The primary outcome measure was the hip outcome score activities of daily living subscale (HOS ADL) at eight months post-randomisation, with a minimum clinically important difference between groups of 9 points. Secondary outcome measures included additional patient reported outcome measures and clinical assessment.

Results: At eight months post-randomisation, data were available for 100 patients in the arthroscopic hip surgery group (89%) and 88 patients in the physiotherapy programme group (80%). Mean HOS ADL was 78.4 (95% confidence interval 74.4 to 82.3) for patients randomised to arthroscopic hip surgery and 69.2 (65.2 to 73.3) for patients randomised to the physiotherapy programme. After adjusting for baseline HOS ADL, age, sex, and study site, the mean HOS ADL was 10.0 points higher (6.4 to 13.6) in the arthroscopic hip surgery group compared with the physiotherapy programme group (P<0.001)). No serious adverse events were reported in either group.

Conclusions: Patients with symptomatic FAI referred to secondary or tertiary care achieve superior outcomes with arthroscopic hip surgery than with physiotherapy and activity modification.

Trial Registration: ClinicalTrials.gov NCT01893034.
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http://dx.doi.org/10.1136/bmj.l185DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6365841PMC
February 2019

Anterior cruciate ligament (ACL) reconstruction and meniscal repair rates have both increased in the past 20 years in England: hospital statistics from 1997 to 2017.

Br J Sports Med 2020 Mar 19;54(5):286-291. Epub 2019 Jan 19.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Objectives: We investigated the temporal trend and the geographical variation in the rate of an anterior cruciate ligament (ACL) reconstruction and meniscal repair (MR) performed in England during a 20-year window.

Methods: All hospital episodes for patients undergoing ACL reconstruction or MR between 1 April 1997 and 31 March 2017 were extracted by procedure code from the national hospital episode statistics. Age-standardised and sex-standardised rates of surgery were calculated using Office for National Statistics population data as the denominator and analysed over time both nationally and regionally by National Health Service clinical commissioning group (CCG).

Results: Between 1997-1998 and 2016-2017, there were 133 270 cases of ACL reconstruction (124 489 patients) and 42 651 cases of MR (41 120 patients) (isolated or simultaneous). Nationally, the rate of ACL reconstruction increased 12-fold from 2.0/100K population (95% CI 1.9 to 2.1) in 1997-1998 to 24.2/100K (95% CI 23.8 to 24.6) in 2016-2017. The rate of MR increased more than twofold from 3.0/100K (95% CI 2.8 to 3.1) in 1997-1998 to 7.3/100K (95% CI 7.1 to 7.5) in 2016-2017. Of these cases, the rate of simultaneous ACL reconstruction and MR was 2.6/100K (95% CI 2.5 to 2.8) in 2016/2017. In 2016-2017, for patients aged 20-29, the sex-standardised rate of ACL reconstruction was 76.9/100K (95% CI 74.9 to 78.9) and for MR was 19.8/100K (95% CI 18.8 to 20.9). Practice varied by region-in 2016-2017, 14.5% (30/207) of the CCGs performed more than twice the national average rate of ACL reconstruction and 15.0% (31/207) performed more than twice the national average rate of MR.

Conclusions: The rate of ACL reconstruction (12-fold) and MR (2.4-fold) has increased in England over the last two decades. There is variation in these rates across geographical regions and further work is required to deliver standardised treatment guidance for appropriate use.
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http://dx.doi.org/10.1136/bjsports-2018-100195DOI Listing
March 2020

Patch-augmented rotator cuff surgery (PARCS) study-protocol for a feasibility study.

Pilot Feasibility Stud 2018 21;4:188. Epub 2018 Dec 21.

2NIHR Oxford Biomedical Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Background: A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery and the use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Patches have been made using different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh). However, clinical evidence on their use is limited. The aim of the patch-augmented rotator cuff surgery (PARCS) feasibility study is to determine, using a mixed method approach, the design of a definitive randomised trial assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible.

Methods: The objectives of this six-stage mixed methods feasibility study are to determine current practice, evidence and views about patch use; achieve consensus on the design of a randomised trial to evaluate patch-augmented rotator cuff surgery; and assess the acceptability and feasibility of the proposed design. The six stages will involve a systematic review of clinical evidence, two surveys of surgeons, focus groups and interviews with stakeholders, a Delphi study and a consensus meeting. The various stakeholders (including patients, surgeons, and representatives from industry, the NHS and regulatory bodies) will be involved across the six stages.

Discussion: The PARCS feasibility study will inform the feasibility and acceptability of a randomised trial of the effectiveness and cost-effectiveness of a patch-augmented rotator cuff surgery. Consensus opinion on the basic design of a randomised trial will be sought.

Trial Registration: Not applicable.
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http://dx.doi.org/10.1186/s40814-018-0380-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6302398PMC
December 2018

The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation.

J Clin Epidemiol 2019 02 16;106:108-120. Epub 2018 Oct 16.

Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom; NIHR Collaboration for Leadership in Applied Health Research and Care at University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.

Objective: To evaluate the impact of the QuinteT Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties and then implements "QRI actions" to address these as recruitment proceeds.

Study Design And Setting: A mixed-methods study, comprising (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) qualitative case studies, including documentary analysis and interviews with RCT investigators.

Results: Five UK-based publicly funded RCTs were included in the evaluation. All recruited to target. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI actions in RCTs 1, 3, 4, and 5. Randomization rates significantly improved after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action.

Conclusion: There is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.
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http://dx.doi.org/10.1016/j.jclinepi.2018.10.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355457PMC
February 2019

Temporal trends and regional variation in the rate of arthroscopic knee surgery in England: analysis of over 1.7 million procedures between 1997 and 2017. Has practice changed in response to new evidence?

Br J Sports Med 2019 Dec 2;53(24):1533-1538. Epub 2018 Oct 2.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Objectives: We investigated trends and regional variation in the rate of arthroscopic knee surgery performed in England from 1997-1998 to 2016-2017.

Design: Cross-sectional study of the national hospital episode statistics (HES) for England.

Methods: All hospital episodes for patients undergoing a knee arthroscopy between 1 April 1997 and 31 March 2017 were extracted from HES by procedure code. Age and sex-standardised rates of surgery were calculated using Office for National Statistic population data as the denominator. Trends in the rate of surgery were analysed by procedure both nationally and by Clinical Commissioning Group (CCG).

Results: A total of 1 088 872 arthroscopic partial meniscectomies (APMs), 326 600 diagnostic arthroscopies, 308 618 knee washouts and 252 885 chondroplasties were identified (1 759 467 hospital admissions; 1 447 142 patients). The rate of APM increased from a low of 51/100 000 population (95% CI 51 to 52) in 1997-1998 to a peak at 149/100 000 (95% CI 148 to 150) in 2013-2014; then, after 2014-2015, rates declined to 120/100 000 (95% CI 119 to 121) in 2016-2017. Rates of arthroscopic knee washout and diagnostic arthroscopy declined steadily from 50/100 000 (95% CI 49 to 50) and 47/100 000 (95% CI 46 to 47) respectively in 1997-1998, to 4.8/100 000 (95% CI 4.6 to 5.0) and 8.1/100 000 (95% CI 7.9 to 8.3) in 2016-2017. Rates of chondroplasty have increased from a low of 3.2/100 000 (95% CI 3.0 to 3.3) in 1997-1998 to 51/100 000 (95% CI 50.6 to 51.7) in 2016-2017. Substantial regional and age-group variation in practice was detected. In 2016-2017, between 11% (22/207) and 16% (34/207) of CCGs performed at least double the national average rate of each procedure.

Conclusions: Over the last 20 years, and likely in response to new evidence, rates of arthroscopic knee washout and diagnostic arthroscopy have declined by up to 90%. APM rates increased about 130% overall but have declined recently. Rates of chondroplasty increased about 15-fold. There is significant variation in practice, but the appropriate population intervention rate for these procedures remains unknown.
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http://dx.doi.org/10.1136/bjsports-2018-099414DOI Listing
December 2019

Adverse outcomes after arthroscopic partial meniscectomy: a study of 700 000 procedures in the national Hospital Episode Statistics database for England.

Lancet 2018 11 24;392(10160):2194-2202. Epub 2018 Sep 24.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Background: Arthroscopic partial meniscectomy is one of the most common orthopaedic procedures worldwide. Clinical trial evidence published in the past 6 years, however, has raised questions about the effectiveness of the procedure in some patient groups. In view of concerns about potential overuse, we aimed to establish the true risk of serious complications after arthroscopic partial meniscectomy.

Methods: We analysed national Hospital Episode Statistics data for all arthroscopic partial meniscectomies done in England between April 1, 1997, and March 31, 2017. Simultaneous or staged (within 6 months) bilateral cases were excluded. We identified complications occurring in the 90 days after the index procedure. The primary outcome was the occurrence of at least one serious complication within 90 days, which was defined as either myocardial infarction, stroke, pulmonary embolism, infection requiring surgery, fasciotomy, neurovascular injury, or death. Logistic regression modelling was used to identify factors associated with complications and, when possible, risk was compared with general population data.

Findings: During the study period 1 088 782 arthroscopic partial meniscectomies were done, 699 965 of which were eligible for analysis. Within 90 days, serious complications occurred in 2218 (0·317% [95% CI 0·304-0·330]) cases, including 546 pulmonary embolisms (0·078% [95% CI 0·072-0·085]) and 944 infections necessitating further surgery (0·135% [95% CI 0·126-0·144]). Increasing age (adjusted odds ratio [OR] 1·247 per decade [95% CI 1·208-1·288) and modified Charlson comorbidity index (adjusted OR 1·860 per 10 units [95% CI 1·708-2·042]) were associated with an increased risk of serious complications. Female sex was associated with a reduced risk of serious complications (adjusted OR 0·640 [95% CI 0·580-0·705). The risk of mortality fell over time (adjusted OR 0·965 per year [95% CI 0·937-0·994]). Mortality, myocardial infarction, and stroke occurred less frequently in the study cohort than in the general population. The risks of infection and pulmonary embolism did not change during the study, and were significantly higher in the study cohort than in the general population. For every 1390 (95% CI 1272-1532) fewer knee arthroscopies done, one pulmonary embolism could be prevented. For every 749 (95% CI 704-801) fewer procedures done, one native knee joint infection could be prevented.

Interpretation: Overall, the risk associated with undergoing arthroscopic partial meniscectomy was low. However, some rare but serious complications (including pulmonary embolism and infection) are associated with the procedure, and the risks have not fallen with time. In view of uncertainty about the effectiveness of arthroscopic partial meniscectomy, an appreciation of relative risks is crucial for patients and clinicians. Our data provide a basis for decision making and consent.

Funding: UK National Institute for Health Research.
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http://dx.doi.org/10.1016/S0140-6736(18)31771-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6238020PMC
November 2018

Can Shoulder Arthroscopy Work? (CSAW) trial - Authors' reply.

Lancet 2018 07;392(10144):281-282

Royal College of Surgeons (England) Surgical Interventional Trials Unit (SITU), Botnar Research Centre, Headington, Oxford, OX3 7LD, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, National Institute of Health Research (NIHR) Biomedical Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.

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http://dx.doi.org/10.1016/S0140-6736(18)30773-6DOI Listing
July 2018

Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework.

Trials 2018 Jan 19;19(1):50. Epub 2018 Jan 19.

School of Social and Community Medicine, University of Bristol, 39 Whatley Road, Bristol, BS8 2PS, UK.

Background: Research has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexity of this pathway means that many patients do not have the opportunity to consider participation. This article presents the development of a simple framework to document, understand and improve the process of trial recruitment.

Methods: Eight RCTs integrated a QuinteT Recruitment Intervention (QRI) into the main trial, feasibility or pilot study. Part of the QRI required mapping the patient recruitment pathway using trial-specific screening and recruitment logs. A content analysis compared the logs to identify aspects of the recruitment pathway and process that were useful in monitoring and improving recruitment. Findings were synthesised to develop an optimised simple framework that can be used in a wide range of RCTs.

Results: The eight trials recorded basic information about patients screened for trial participation and randomisation outcome. Three trials systematically recorded reasons why an individual was not enrolled in the trial, and further details why they were not eligible or approached, or declined randomisation. A framework to facilitate clearer recording of the recruitment process and reasons for non-participation was developed: SEAR - Screening, to identify potentially eligible trial participants; Eligibility, assessed against the trial protocol inclusion/exclusion criteria; Approach, the provision of oral and written information and invitation to participate in the trial, and Randomised or not, with the outcome of randomisation or treatment received.

Conclusions: The SEAR framework encourages the collection of information to identify recruitment obstacles and facilitate improvements to the recruitment process. SEAR can be adapted to monitor recruitment to most RCTs, but is likely to add most value in trials where recruitment problems are anticipated or evident. Further work to test it more widely is recommended.
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http://dx.doi.org/10.1186/s13063-017-2413-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5775609PMC
January 2018

Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial.

Lancet 2018 01 20;391(10118):329-338. Epub 2017 Nov 20.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, National Institute of Health Research (NIHR) Biomedical Research Centre, University of Oxford, Headington, Oxford, UK. Electronic address:

Background: Arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression.

Methods: We did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011.

Findings: Between Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment. Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference -1·3 points (95% CI -3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5-5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8-6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group).

Interpretation: Surgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process.

Funding: Arthritis Research UK, the National Institute for Health Research Biomedical Research Centre, and the Royal College of Surgeons (England).
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http://dx.doi.org/10.1016/S0140-6736(17)32457-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5803129PMC
January 2018