Publications by authors named "Henrik Morville Schrøder"

14 Publications

  • Page 1 of 1

One-stage versus two-stage revision of the infected knee arthroplasty - a randomized multicenter clinical trial study protocol.

BMC Musculoskelet Disord 2021 Feb 12;22(1):175. Epub 2021 Feb 12.

Department of Orthopaedic Surgery, Næstved Hospital, Næstved, Denmark.

Background: A two-stage prosthesis exchange procedure has been the gold standard in surgical treatment of the chronically infected knee arthroplasty so far. This includes 2 surgeries/hospitalizations and an interim period of 2-3 months between surgeries with impaired health, functional status and quality of life of the patients. A one-stage exchange procedure holds many obvious advantages compared to the two-stage approach, but outcomes of a one-stage versus two-stage procedures have never been investigated in a randomized clinical trial. The purpose of this study is primarily to investigate time-adjusted differences in functional status of patients after one-stage versus two-stage revision. Secondary, to report time-adjusted differences in quality of life, complications (including re-revisions due to infection) and mortality.

Methods: This study is a pragmatic, multi-center, randomized, non-inferiority trial comparing one-stage versus two-stage revision of the infected knee arthroplasty. Seven Danish hospitals are currently participating in the study, but additional hospitals can enter the study if adhering to protocol. Ninety-six patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 10 years. The patients who are not able to participate in the randomized trial are followed in a parallel cohort study.

Prom's: Oxford Knee Score and EQ5D + EQ5D VAS questionnaires are completed preoperatively and sent out to the study participants at 6 weeks, 3, 6, 9, 12, 18 and 24 months as well as 5 and 10 years postoperatively. In addition a tailor made cost questionnaire on the non-treating hospital resource use, community health and social service use, travel costs, time off work and informal care are sent out.

Discussion: If one of the two treatment alternatives is found superior in both domains of quality of life (both knee-specific and generic) and health economics, that treatment should be promoted. Other outcomes will open informed discussions about treatment strategies for periprosthetic knee infections.

Trial Registration: The randomized trial is registered on ClinicalTrials.gov with ID NCT03435679 , initial release date January 31, 2018 and the cohort study is registered with ID NCT04427943 , submitted January 8, 2020 and posted June 11, 2020.
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http://dx.doi.org/10.1186/s12891-021-04044-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7881574PMC
February 2021

Establishing research priorities related to osteoarthritis care via stakeholder input from patients.

Dan Med J 2021 Jan 26;68(2). Epub 2021 Jan 26.

Introduction: Stakeholder involvement in research is emphasised to improve relevance. We aimed to identify, define and prioritise important research topics seen from the point of view of people with osteoarthritis (OA).

Methods: We invited 1,315 members of the user panel of the Danish Rheumatism Association to answer an electronic survey that included; 1) an open-ended question about important research topics (free-text response option), 2) 15 predefined research topics to be rated for importance and 3) predefined topics grouped into four categories in which the most important was prioritised. Free-text responses were analysed using content analysis.

Results: Out of 850 (65%) respondents, 483 had OA (mean ± standard deviation age 60.3 ± 10.2 years, 91% female). From the free-text responses, we identified seven research topics; 1) diagnostics, 2) prevention, 3) side effects, 4) treatment, 5) aetiology, 6) being young with OA and 7) quality of life. For "treatment", we identified seven subtopics. Out of all topics and subtopics, "pain management" was the most frequently highlighted. All predefined topics were rated as "very important" or "somewhat important" by more than 75% of the respondents. The top prioritised topics within each category were 1) improving the diagnosis, 2) individualised treatment, 3) shared decision-making and 4) cross-sector collaboration and collaboration between professionals.

Conclusions: We identified research topics that were important in the eyes of people with OA and found that "pain management" was particularly emphasised.

Funding: none.

Trial Registration: not relevant.
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January 2021

Muscle Function Tests as Supportive Outcome Measures for Performance-Based and Self-Reported Physical Function in Patients With Knee Osteoarthritis: Exploratory Analysis of Baseline Data From a Randomized Trial.

J Strength Cond Res 2020 Oct 5. Epub 2020 Oct 5.

Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.

Holm, PM, Kemnitz, J, Bandholm, T, Wernbom, M, Schrøder, HM, and Skou, ST. Muscle function tests as supportive outcome measures for performance-based and self-reported physical function in patients with knee osteoarthritis: Exploratory analysis of baseline data from a randomized trial. J Strength Cond Res XX(X): 000-000, 2020-Uncertainty on the role of muscle function in relation to physical function in knee osteoarthritis (KOA) persists. This study aimed to assess the associations between muscle function and performance-based and self-reported physical function in patients with KOA. Physical function in 80 subjects with symptomatic and radiographic KOA was assessed using 40-m fast-paced walk, 30-second chair stand, 9-step stair climb tests, and the subscale activities of daily living from the Knee injury and Osteoarthritis Outcome Score (KOOS-ADL). Measurements of muscle function included leg extension (LE) power, knee extension (KE) torque, and estimated leg press one repetition maximum (LP RM). Associations were investigated using multivariable hierarchical linear regressions adjusted for age, sex, body mass index, self-reported physical activity, and thigh muscle lean area. Leg extension power was significantly associated with 40-m walk, stair climb, and 30-second chair stand, explaining 18, 8, and 3% of additional variance, respectively. Knee extension torque explained 13, 7, 17, and 7% of additional variance in the 40-m walk, stair climb, 30-second chair stand, and KOOS-ADL, respectively. Leg press one repetition maximum explained 11% of additional variance in the 30-second chair stand. In conclusion, LE power was the best explanatory variable for performance on the 40-m walk and stair climb tests, whereas KE torque best explained chair stand performance. Only KE torque was associated with KOOS-ADL. Our results highlight the importance of selecting supportive muscle function tests based on the specific physical function and suggest that other factors may be more important for certain physical function outcomes. Level of significance p < 0.05. Trial identifier: NCT03215602.
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http://dx.doi.org/10.1519/JSC.0000000000003840DOI Listing
October 2020

Patient-reported outcomes of 7133 distal femoral, patellar, and proximal tibial fracture patients: A national cross-sectional study with one-, three-, and five-year follow-up.

Knee 2020 Oct 27;27(5):1310-1324. Epub 2020 Jul 27.

Department of Clinical Epidemiology, Aarhus University Hospital, Olof Palmes Allé 43-45, 8200 Aarhus, Denmark.

Background: Few studies have described patient-reported outcome measures (PROMs) in knee fracture patients. We reported knee-specific and generic median PROM scores after knee fracture and identified risk factors for poor outcome defined by low median PROM scores.

Methods: In a Danish cross-sectional study of 7133 distal femoral, patellar, and proximal tibial fracture patients during 2011-2017, OKS, FJS-12, EQ5D-5L Index, and EQ5D-5L Visual Analogue Scale (VAS), were collected electronically (response rate 53%; median age 60; 63% female). Poor outcome was defined as score lower than median PROM score. Poor outcome risk factors were estimated as odds ratios from binary logistic regression models.

Results: At 0 to one year after knee fracture, median PROM scores were 31 (OKS), 27 (FJS-12), 0.50 (EQ5D-5L Index), and 74 (EQ5D-5L VAS). At >5 years after knee fracture, median OKS score was 40, median FJS-12 score was 54, median EQ5D-5L Index was 0.76, and median EQ5D-5L VAS score was 80. Age > 40 years had higher odds for poor OKS and FJS-12 scores at short- and long-term follow-up after knee fracture. Comorbidity burden, distal femoral fracture, and treatment with external fixation and knee arthroplasty were risk factors for poor outcome at long-term follow-up, for all four PROMs.

Conclusions: Although knee fracture patients have relatively high knee function and quality of life, their ability to forget about the knee joint after knee fracture is compromised. We identified several important risk factors for poor outcome measured by PROMs at different follow-up periods following knee fracture, which will help direct future quality-improvement initiatives.
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http://dx.doi.org/10.1016/j.knee.2020.06.006DOI Listing
October 2020

Differences in patient characteristics and external validity of randomized clinical trials on pain management following total hip and knee arthroplasty: a systematic review.

Reg Anesth Pain Med 2020 Sep 28;45(9):709-715. Epub 2020 Jul 28.

Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital Koge, Koge, Denmark.

Background: The external validity of randomized controlled trials (RCTs) is critical for the relevance of trial results in a clinical setting. We aimed to assess the external validity of RCTs investigating postoperative pain treatment after total hip and knee arthroplasty (THA and TKA) by comparing patient characteristics in these trials with a clinical cohort. Further, we assessed the use of exclusion criteria of the included RCTs.

Methods: We searched PubMed, Embase, and Cochrane Central Register of Controlled Trials for relevant RCTs up to June 2019. Data on patient characteristics from this research population were compared with an unselected clinical cohort from the Danish Hip and Knee Arthroplasty Registries in the period 2005-2019. Trends in patient characteristics and the use of exclusion criteria were assessed with control charts.

Results: In total, 550 RCTs with 48 962 participants were included in the research cohort. The clinical cohort included 101 439 THA patients and 90 505 TKA patients. Patient characteristics (age, body mass index (BMI), American Society of Anesthesiologists (ASA) score and sex distribution) in the research cohort resembled those of the clinical cohort. Age, BMI and ASA scores did not change over time in the research cohort. In the clinical cohort, age increased among both THA and TKA patients, and BMI and ASA scores increased among TKA patients. Most commonly used exclusion criteria in the RCTs were high ASA score (62%), older age (45%), obesity (32%) and chronic opioid use (41%). Exclusion of chronic opioid users and individuals with obesity increased over time.

Conclusion: Patient characteristics in research trials investigating postoperative pain management after THA and TKA currently resemble those of a clinical cohort. However, individuals in the clinical cohort are getting older, and TKA patients more obese with increasing ASA scores. Concomitantly, RCTs increase the tendency to exclude patients with older age, obesity, chronic pain and/or opioid use. This trending discrepancy can hinder the generalizability of future research results, and therefore increased focus on pragmatic trials resembling real-world conditions are needed.

Prospero Registration Number: CRD42019125691.
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http://dx.doi.org/10.1136/rapm-2020-101459DOI Listing
September 2020

Intrarater Reliability and Agreement of Recommended Performance-Based Tests and Common Muscle Function Tests in Knee Osteoarthritis.

J Geriatr Phys Ther 2020 Apr 9. Epub 2020 Apr 9.

Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.

Background And Purpose: Some uncertainty persists regarding the reproducibility of the recommended core set of performance-based tests, as well as common muscle function tests, when applied in individuals with knee osteoarthritis (KOA). The purpose of this study was to investigate the intrarater reliability and agreement of the recommended core set of performance-based tests and common muscle function tests in KOA.

Methods: Participants (N=40) with radiographic and/or symptomatic KOA were evaluated twice with a 3-day interval between test sessions using the following tests: Leg extensor (LE) maximal muscle power measured in a Nottingham Power Rig; knee extensor (KE) peak isometric strength measured with a handheld dynamometer; 40-m walk test; 30-second chair-stand test; and 9-step stair climb test. Reliability was assessed using a 2-way, mixed-effects, single-measures model (3,1), absolute agreement-type intraclass correlation coefficient (ICC). Agreement was assessed using 95% limits of agreement (LOA) and LOA relative to the mean score from test and retest (LOA-%).

Results: Reliability for all tests was very high (ICC ≥ 0.97). LOA (LOA-%) was ±32.3 watt (W) (±22%) for LE power; ±22.7 N·m (±24%) for KE strength; ±0.2 m/s (±10%) for 40-m walk test; ±2.4 repetitions (±14%) for 30-second chair-stand test; and ±2 second (±20%) for stair climb test. A potential participant learning effect was found for all 3 performance-based tests, indicated by the significantly better scores at retest.

Discussion: The very high reliability found for the performance-based tests supports findings from previous studies and confirms discriminate reliability of these tests on a group level. Also, very high reliability estimates were demonstrated for both muscle function tests. This study also provided estimates of agreement for both performance-based and muscle function tests, which are important to consider when using these tests on an individual level in clinical practice.

Conclusion: When using these tests to monitor changes over time in the clinic, depending on the test, improvements of less than 10% to 24% could be a result of measurement error alone and therefore may not be considered an actual improvement after treatment.
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http://dx.doi.org/10.1519/JPT.0000000000000266DOI Listing
April 2020

No-Fault Compensation From the Patient Compensation Association in Denmark After Primary Total Hip Replacement in Danish Hospitals 2005-2017.

J Arthroplasty 2020 07 25;35(7):1784-1791. Epub 2020 Feb 25.

Department of Orthopedic Surgery, Næstved Hospital, Næstved, Denmark.

Background: There is an annually rising number of performed total hip arthroplasty (THA) surgeries in Denmark and this is expected to become even more common. However, there are still risks of adverse events, which become the basis for compensation claims. In Denmark, there are no studies available concerning filed claims after THA. The aims of this study are to determine the incidence of claims related to THAs in Denmark, the reasons to claim, which claims lead to compensation, the amount of compensation, and trends over time.

Methods: In this observational study, we analyzed all closed claims between 2005 and 2017 from the Danish Patient Compensation Association (DPCA). With the intention to contribute to prevention, we have identified the number and outcome of claims.

Results: There were 2924 cases (ie, 2.5% of all THAs performed in this period). The approval rate was 54%. The number of claims filed was stagnant over time, except for a spike of metal-on-metal (MoM) prosthesis cases. The total payout was USD 29,591,045, and 87% of this was due to nerve damage (USD 9,106,118), infection (USD 6,046,948), MoM prosthesis (USD 4,624,353), insufficient or incorrect treatment (USD 472,500), and fracture (USD 2,088,110).

Conclusion: In total, 2.5% of all THAs performed between 2005 and 2017 lead to a claim submission at the DPCA. One of 2 claims were approved. The majority of payouts were due to nerve damage, infection, MoM prosthesis, insufficient or incorrect treatment, and fracture. Although DPCA manages claims for patients, the data can also provide beneficial feedback to arthroplasty surgeons with the aim of improving patient care.
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http://dx.doi.org/10.1016/j.arth.2020.02.042DOI Listing
July 2020

Knee Fracture Increases TKA Risk After Initial Fracture Treatment and Throughout Life.

Clin Orthop Relat Res 2020 Sep;478(9):2036-2044

V. Vestergaard, The Harris Orthopaedics Laboratory, Department of Orthopaedic Surgery, Massachusetts General Hospital, Boston, MA, USA.

Background: Knee fractures may lead to post-traumatic knee osteoarthritis and subsequent TKA in some patients. However, absolute risk estimates and risk factors for TKA in patients with knee fractures compared with those of the general population remain largely unknown. Such knowledge would help establish the treatment burden and direct patient counseling after a knee fracture is sustained.

Questions/purposes: (1) What is the short-term risk of TKA after knee fracture? (2) What is the long-term risk of TKA after knee fracture? (3) What are the risk factors for TKA in patients with knee fractures?

Methods: A nationwide 20-year, matched-case comparison cohort study of prospectively collected data from the Danish National Patient Registry included all patients at least 15 years old with International Classification of Diseases, 10th revision codes DS724, DS820, or DS821 (knee fractures) on the date their knee fracture was registered. Each patient with a knee fracture was matched (by sex and age) to five people without knee fractures from the general Danish population on the date the knee fracture patient's knee fracture was registered (population controls). Patients with knee fractures and people in the population control group were followed from the date the knee fracture patient's knee fracture was registered to the date of TKA, amputation, knee fusion, emigration, death, or end of follow-up in April 2018. TKA risks for patients with knee fractures versus those for population controls and TKA risk factors in patients with knee fractures were estimated using hazard ratios (HRs) with 95% CIs. A total of 48,791 patients with knee fractures (median age 58 years [interquartile range 41-73]; 58% were female) were matched to 263,593 people in the population control group.

Results: The HR for TKA in patients with knee fractures compared with population controls was 3.74 (95% CI 3.44 to 4.07; p < 0.01) in the first 3 years after knee fracture. Among knee fracture patients, the risk of undergoing TKA was 2% (967 of 48,791) compared with 0.5% (1280 of 263,593) of people in the population control group. After the first 3 years, the HR was 1.59 (95% CI 1.46 to 1.71) and the number of patients with knee fractures with TKA events divided by the number at risk was 2% (849 of 36,272), compared with 1% (2395 of 180,418) of population controls. During the 20-year study period, 4% of patients with knee fractures underwent TKA compared with 1% of population controls. Risk factors for TKA in patients with knee fractures were: primary knee osteoarthritis (OA) versus no primary knee OA (HR 9.57 [95% CI 5.39 to 16.98]), surgical treatment with external fixation versus open reduction and internal fixation and reduction only (HR 1.92 [95 % CI 1.01 to 3.66]), proximal tibia fracture versus patellar fracture (HR 1.75 [95 % CI 1.30 to 2.36]), and distal femur fracture versus patellar fracture (HR 1.68 [95 % CI 1.08 to 2.64]). Surgical treatment of knee fractures was also a risk factor for TKA. The HRs for TKA in patients with knee fractures who were surgically treated versus those who were treated non-surgically were 2.05 (95% CI 1.83 to 2.30) in the first 5 years after knee fracture and 1.19 (95% CI 1.01 to 1.41) after 5 years.

Conclusions: Patients with knee fractures have a 3.7 times greater risk of TKA in the first 3 years after knee fracture, and the risk remains 1.6 times greater after 3 years and throughout their lifetimes. Primary knee OA, surgical treatment of knee fractures, external fixation, proximal tibia fractures, and distal femur fractures are TKA risk factors. These risk estimates and risk factors highlight the treatment burden of knee fractures, building a foundation for future studies to further counsel patients on their risk of undergoing TKA based on patient-, fracture-, and treatment-specific factors.

Level Of Evidence: Level III, prognostic study.
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http://dx.doi.org/10.1097/CORR.0000000000001099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7431252PMC
September 2020

20-year trends of distal femoral, patellar, and proximal tibial fractures: a Danish nationwide cohort study of 60,823 patients.

Acta Orthop 2020 02 4;91(1):109-114. Epub 2019 Dec 4.

Department of Orthopaedic Surgery, Slagelse Hospital, Naestved, Slagelse and Ringsted Hospitals, Slagelse, Denmark.

Background and purpose - Knee fracture treatment burden remains unknown, impeding proper use of hospital resources. We examined 20-year trends in incidence rates (IRs) and patient-, fracture-, and treatment-related characteristics of knee fracture patients.Patients and methods - This nationwide cohort study of prospectively collected data including patients with distal femoral, patellar, and proximal tibial fractures from the Danish National Patient Registry during 1998-2017, assesses IRs of knee fractures (per 10 inhabitants) as well as patient-, fracture-, and treatment-related characteristics of knee fracture patients.Results - During 1998-2017, 60,823 patients (median age 55; 57% female) sustained 74,106 knee fractures. 74% of the study population had a Charlson Comorbidity Index (CCI) of 0 and 18% a CCI of ≥ 2. 51% were proximal tibial fractures, 31% patellar fractures, and 18% distal femoral fractures. At the time of knee fracture, 20% patients had concomitant near-knee fractures (femur/tibia/fibula shaft/hip/ankle), 13% concomitant fractures (pelvic/spine/thorax/upper extremities), 5% osteoporosis, and 4% primary knee osteoarthritis. Over 1/3 knee fractures were surgically treated and of these 86% were open-reduction internal fixations, 9% external fixations, and 5% knee arthroplasties. The most common surgery type was proximal tibia plating (n = 4,868; 60% female). Knee fracture IR increased 12% to 70, females aged > 51 had the highest knee fracture IR, proximal tibial fracture had the highest knee fracture type IR (32) and surgically treated knee fracture IR increased 35% to 23.Interpretation - Knee fracture IRs, especially of surgically treated knee fractures, are increasing and proximal tibial fracture has the highest knee fracture type IR. Females aged > 51 and patients with comorbidity are associated with knee fracture, proximal tibial fracture, proximal tibial fracture surgery, and posttraumatic knee arthroplasty.
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http://dx.doi.org/10.1080/17453674.2019.1698148DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006734PMC
February 2020

Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis. The study-protocol.

BMC Musculoskelet Disord 2019 Mar 20;20(1):119. Epub 2019 Mar 20.

Department of Orthopedic Surgery, Gentofte Hospital, Kildegårdsvej 28, DK-2900, Hellerup, Denmark.

Background: In treatment of isolated medial unicondylar osteoarthritis of the knee, it is possible to choose between medial unicondylar knee arthroplasty (mUKA), or a total knee prosthesis (TKA). The demand for a blinded multicenter RCT with the comparison of mUKA and TKA has been increasing in recent years, to determine which prosthesis is better. Supporters of TKA suggest this treatment gives a more predictable and better result, whereas supporters of UKA suggest it is unnecessary to remove functional cartilage in other compartments. If the mUKA is worn or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be more problematic.

Methods: A double-blinded multicenter Randomized Clinical Trial setup is the aim of the study. 6 hospitals throughout all 5 municipal regions of Denmark will be participating in the study. 350 patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 20 years.

Discussion: Results will be assessed in terms of 1) PROM-questionnaires, 2) Clinical assessment of knee condition, 3) cost analysis. To avoid bias, all participants except the theatre-staff will be blinded.

Proms: OKS, KOOS, SF36, Forgotten Joint Score, EQ5D, UCLA activity scale, Copenhagen Knee ROM scale, and Anchor questions. Publications are planned at 2, 5 and 10 years after inclusion of the last patient. The development of variables over time will be analyzed by calculating the area under the curve (AUC) for the variable relative to the initial value, and comparisons of the between-group differences will be based on parametric statistics. In this study, we feel that we have designed a study that will address these concerns with a well-designed double-blinded multicentre RCT.

Trial Registration: ClinicalTrials.gov ID: NCT03396640 . Initial Release: 09/19/2017. Date of enrolment of first participant: 10/11/17.
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http://dx.doi.org/10.1186/s12891-019-2508-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425587PMC
March 2019

Prospective psychometric characterization of hip and knee arthroplasty patients.

Nord J Psychiatry 2018 Jan 12;72(1):39-44. Epub 2017 Oct 12.

i Psychiatric Research Unit , Psychiatric Centre North Zealand, University of Copenhagen , Hillerød , Denmark.

Background: Psychiatric conditions and psychopharmacological treatments have been demonstrated to be important risk-factors for prolonged hospital length of stay, readmission and morbidity, following fast-track total hip (THA) and total knee arthroplasty (TKA).

Aims: The aim of the study was to provide a detailed description of the preoperative psychiatric characteristics of a well-defined patient population undergoing THA and TKA, using the 90-item Symptom Checklist (SCL-90-R).

Methods: A pre-surgical population of 2183 patients completed the full SCL-90-R prior to THA/TKA from 2015 to 2016. The SCL-90-R scale and total scores of the pre-surgical sample were compared to the scores of an age- and gender stratified Danish sample of healthy controls. A Mokken scalogram analysis was conducted to assess the scalability of the SCL-90-R in both samples.

Results: The Mokken analysis yielded acceptable scalability coefficients above 0.30 in all subscales of the SCL-90-R except psycoticism (0.28). There was no clinically significant difference (effect size = <0.50) in the SCL-90-R total score between the pre-surgical and the healthy controls samples, although pre-surgical patients had lower mean scores compared to the healthy controls in all subscales except somatization (effect size = -0.22).

Conclusion: The Mokken analysis demonstrated that the SCL-90-R and its subscales express valid measures of psychopathology in our surgical sample. The psychiatric profile of the pre-surgical patient sample indicates that patients undergoing THA/TKA are not more burdened by psychiatric symptoms than a healthy control group with the exception of symptoms relating to somatization.
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http://dx.doi.org/10.1080/08039488.2017.1381149DOI Listing
January 2018

PANSAID-PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial.

Trials 2017 Oct 10;18(1):465. Epub 2017 Oct 10.

Copenhagen Trial Unit, Rigshospitalet, Dept. 7812, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark.

Background: Effective postoperative pain management is essential for the rehabilitation of the surgical patient. The PANSAID trial evaluates the analgesic effects and safety of the combination of paracetamol and ibuprofen. This paper describes in detail the statistical analysis plan for the primary publication to prevent outcome reporting bias and data-driven analysis results.

Methods/design: The PANSAID trial is a multicentre, randomised, controlled, parallel, four-group clinical trial comparing the beneficial and harmful effects of different doses and combinations of paracetamol and ibuprofen in patients having total hip arthroplastic surgery. Patients, caregivers, physicians, investigators, and statisticians are blinded to the intervention. The two co-primary outcomes are 24-h consumption of morphine and proportion of patients with one or more serious adverse events within 90 days after surgery. Secondary outcomes are pain scores during mobilisation and at rest at 6 and 24 h postoperatively, and the proportion of patients with one or more adverse events within 24 h postoperatively.

Discussion: PANSAID will provide a large trial with low risk of bias regarding benefits and harms of the combination of paracetamol and ibuprofen used in a perioperative setting.

Trial Registration: ClinicalTrials.org identifier: NCT02571361 . Registered on 7 October 2015.
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http://dx.doi.org/10.1186/s13063-017-2203-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5634901PMC
October 2017

PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial.

Trials 2017 01 10;18(1):11. Epub 2017 Jan 10.

Department of Anaesthesiology, Zealand University Hospital Køge, Lykkebækvej 1, 4600, Køge, Denmark.

Background: Effective postoperative pain management is essential for the rehabilitation of the surgical patient. No 'gold standard' exists after total hip arthroplasty (THA) and combinations of different nonopioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy. The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen alone and in combination in different dosages after THA.

Methods: PANSAID is a placebo-controlled, parallel four-group, multicentre trial with centralised computer-generated allocation sequence and allocation concealment and with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients and statisticians. Patients are randomised to four groups: (A) paracetamol 1 g × 4 and ibuprofen 400 mg × 4, (B) paracetamol 1 g × 4 and placebo, (C) placebo and ibuprofen 400 mg × 4 and (D) paracetamol 0.5 g × 4 and ibuprofen 200 mg. The two co-primary outcomes are 24-h consumption of morphine and number of patients with one or more serious adverse events within 90 days after surgery. Secondary outcomes are pain scores during mobilisation and at rest at 6 and 24 h postoperatively, and number of patients with one or more adverse events within 24 h postoperatively. Inclusion criteria are patients scheduled for unilateral, primary THA; age above 18 years; ASA status 1-3; BMI >18 and <40 kg/m; women must not be pregnant; and provision of informed consent. Exclusion criteria are patients who cannot cooperate with the trial; participation in another trial; patients who cannot understand/speak Danish; daily use of strong opioids; allergy against trial medication; contraindications against ibuprofen; alcohol and/or drug abuse. A total of 556 eligible patients are needed to detect a difference of 10 mg morphine i.v. the first 24 h postoperatively with a standard deviation of 20 mg and a family wise type 1 error rate of 0.025 (two-sided) and a type 2 error rate of 0.10 for the six possible comparisons of the four intervention groups.

Discussion: We started recruiting patients in December 2015 and expect to finish in September 2017. Data analysis will be from September 2017 to October 2017 and manuscript submission ultimo 2017.

Trial Registration: EudraCT: 2015-002239-16 (12/8-15); ClinicalTrials.gov: NCT02571361 . Registered on 7 October 2015.
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http://dx.doi.org/10.1186/s13063-016-1749-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5223299PMC
January 2017

Use of a New Knee Prosthesis as an Articulating Spacer in Two-Stage Revision of Infected Total Knee Arthroplasty.

Knee Surg Relat Res 2016 Sep 25;28(3):239-44. Epub 2016 Aug 25.

Department of Orthopaedic Surgery, Naestved Hospital, Naestved, Denmark.

Purpose: To report our experience with two-stage revision using a new femoral component (NFC) spacer (Depuy Synthes) as an articulating spacer.

Materials And Methods: In this retrospective study, we reviewed 22 two-stage revisions that were performed using an NFC spacer in 22 patients suspected of having an infected total knee arthroplasty (TKA) from December 2010 to March 2013. The result was considered successful when eradication of infection was achieved using only one NFC spacer.

Results: The average time from primary TKA to the first stage procedure was 29.1 months and the average time from the first stage procedure until the final second stage procedure was 12.7 weeks. The average range of motion increased from 82° preoperatively to 104° postoperatively. The American Knee Society Knee score increased from 29.3 points to 66 points. The Function score increased from 29.5 points to 64 points. Four cases were reinfected after two-stage revision. The mean follow-up was 37.6 months.

Conclusions: The new articulating spacer showed promising short-term results both with regard to eradication of infection and functional improvement.
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http://dx.doi.org/10.5792/ksrr.2016.28.3.239DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5009050PMC
September 2016