Publications by authors named "Arild Aamodt"

25 Publications

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Authors' reply to the comment by Riddle et al.

Eur J Pain 2021 05 18;25(5):1173-1174. Epub 2021 Mar 18.

Department of Orthopaedic Surgery, Lovisenberg Diaconal Hospital, Oslo, Norway.

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http://dx.doi.org/10.1002/ejp.1756DOI Listing
May 2021

Antibiotic-Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty: A Register-based Multicentre Randomised Controlled Non-inferiority Trial (ALBA trial).

BMJ Open 2021 01 28;11(1):e041096. Epub 2021 Jan 28.

The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway.

Introduction: The current evidence on the efficacy of antibiotic-loaded bone cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. In several European countries, the use of ALBC is routine practice unlike in the USA where ALBC use is not approved in low-risk patients. Therefore, we designed a double-blinded pragmatic multicentre register-based randomised controlled non-inferiority trial to investigate the effects of ALBC compared with plain bone cement in primary total knee arthroplasty (TKA).

Methods And Analysis: A minimum of 9,172 patients undergoing full-cemented primary TKA will be recruited and equally randomised into the ALBC group and the plain bone cement group. This trial will be conducted in Norwegian hospitals that routinely perform cemented primary TKA. The primary outcome will be risk of revision surgery due to PJI at 1-year of follow-up. Secondary outcomes will be: risk of revision due to any reason including aseptic loosening at 1, 6, 10 and 20 years of follow-up; patient-related outcome measures like function, pain, satisfaction and health-related quality of life at 1, 6 and 10 years of follow-up; risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions at 1, 6, 10 and 20 years of follow-up; cost-effectiveness of routine ALBC versus plain bone cement use in primary TKA. We will use 1:1 randomisation with random permuted blocks and stratify by participating hospitals to randomise patients to receive ALBC or plain bone cement. Inclusion, randomisation and follow-up will be through the Norwegian Arthroplasty Register.

Ethics And Dissemination: The trial was approved by the Western Norway Regional Committees on Medical and Health Research Ethics (reference number: 2019/751/REK vest) on 21 June 2019. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations.

Trial Registration Number: NCT04135170.
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http://dx.doi.org/10.1136/bmjopen-2020-041096DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845702PMC
January 2021

Preoperative risk factors associated with chronic pain profiles following total knee arthroplasty.

Eur J Pain 2021 03 19;25(3):680-692. Epub 2020 Dec 19.

Department of Orthopaedic Surgery, Lovisenberg Diaconal Hospital, Oslo, Norway.

Background: One in five patients experience chronic pain 12 months following total knee arthroplasty (TKA). This longitudinal study used a person-centred approach to identify subgroups of patients with distinct chronic pain profiles following TKA and identified preoperative characteristics associated with these profiles.

Methods: On the day before surgery, 202 patients completed questionnaires that assessed pain, interference with functioning, fatigue, anxiety, depression and illness perceptions. Average and worst pain were assessed prior to surgery, on postoperative day 4, at 6 week and at 3 and 12 months following surgery. Using growth mixture modelling, two subgroups with distinct average and worst pain profiles were identified.

Results: Patients in the "lower average" and "lower worst" pain classes had moderate preoperative pain scores that decreased over the remaining 9 months following TKA. Patients in the "higher average" and "higher worst" pain classes had relatively higher preoperative pain scores that increased during the first three months and then decreased slightly over the remaining 9 months. Patients in the higher pain classes had higher interference with function scores; used opioids prior to surgery more often, were more likely to receive a continuous nerve block and ketamine; had higher preoperative fatigue severity and interference scores; and had worse perceptions of illness than patients in the lower pain classes.

Conclusions: These risk factors may be used to identify subgroups of patients at higher risk for more severe pain after TKA. Future studies should test whether modifying these risk factors can improve patients' outcomes after TKA.

Significance Statement: The present study provides a novel and original analysis of pain profiles following total knee arthroplasty that may contribute to our understanding of the transition from acute to chronic pain. Our results may be used to identify patients at higher risk for poorer outcomes based on preoperative risk factors.
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http://dx.doi.org/10.1002/ejp.1703DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986219PMC
March 2021

High levels of preoperative pain and fatigue are red flags for moderate-severe pain 12 months after total knee arthroplasty-A longitudinal cohort study.

Musculoskeletal Care 2021 06 21;19(2):186-192. Epub 2020 Oct 21.

Department of Nursing Science, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway.

Background: Moderate/severe pain after total knee arthroplasty (TKA) is a poor surgical outcome. Many studies have identified preoperative risk factors of pain after TKA, but studies of the joint contributions of co-occurring symptoms are lacking.

Methods: Patients undergoing primary TKA (n = 202) were enrolled in a longitudinal cohort study. Preoperatively, patients completed questionnaires measuring demographics and symptoms (pain, fatigue, sleep problems and depression). Pain was re-assessed 12 months after TKA. Logistic regression analysis was used to compute the probabilities of moderate-severe pain at 12 months based on preoperative symptom levels, and results were combined into a risk matrix.

Results: More than one-third (40%) of patients (n = 187) reported moderate-severe pain after TKA. Among preoperative risk factors included in the logistic regression analyses were age, sex, pain, fatigue, sleep problems and depression. Adjusting for possible confounders, fatigue (p = 0.02) and pain (p = 0.01) were significant risk factors for moderate-severe pain at 12-months follow-up and were retained in the final risk matrix. The co-occurrence of high-preoperative fatigue and pain scores resulted in 57% estimated probability of moderate-severe pain at 12 months. Similarly, the co-occurrence of low-preoperative fatigue and pain scores resulted in 14% estimated probability of moderate-severe pain 12 months after TKA.

Conclusion: The combination of high fatigue and pain scores prior to surgery was a key risk factor for moderate-severe pain 12 months after TKA. Mapping of these factors could be used preoperatively to identify patients who are at risk to experience a poor outcome of TKA.
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http://dx.doi.org/10.1002/msc.1522DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247059PMC
June 2021

Predictors of chronic pain and level of physical function in total knee arthroplasty: a protocol for a systematic review and meta-analysis.

BMJ Open 2020 09 10;10(9):e037674. Epub 2020 Sep 10.

Department of Patient Safety and Research, Lovisenberg Diaconal Hospital, Oslo, Norway.

Introduction: One in five patients undergoing total knee arthroplasty (TKA) experience unchanged or worse pain and physical function 1 year after surgery. Identifying risk factors for unfavourable outcomes is necessary to develop tailored interventions to minimise risk. There is a need to review more current literature with updated methodology that addresses the limitations of earlier systematic reviews and meta-analyses. We present a Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols compliant protocol for a systematic review and meta-analysis of predictors of chronic pain and impaired function after TKA.

Methods And Analysis: This review will include prospective longitudinal observational studies, or randomised trials (including cluster and crossover designs) that report arm-wise predictors of chronic postsurgical pain or impaired physical function at 3 months, 6 months or 12 months. A comprehensive literature search of studies published between 2000 and 2019 will be performed in Medline, Embase, CINAHL, Cochrane Library and PEDro. Blinded assessment with consensus agreement will be applied for inclusion of studies, data extraction and assessment of bias risk (Quality in Prognosis Studies tool). The co-primary outcomes, pain and impaired function, at 12 months after TKA will be analysed separately. Estimates of association between each outcome and any preoperative or intraoperative factor that may predict chronic pain or impaired physical function will be extracted from the included studies, where possible. For randomised studies, results will only be extracted from TKA arms (or the first period of crossover trials). Estimates of association from the primary evidence will be synthesised narratively, and quantitatively using multivariate meta-analysis to provide 'pooled' estimates of association. Subgroup and sensitivity analyses will be performed. Certainty of evidence for each predictor will be derived from the Grading of Recommendations Assessment, Development and Evaluation framework.

Ethics And Dissemination: No ethical issues are associated with this project. The results from this review will be published in peer-reviewed journals and presented at international conferences.

Prospero Registration Number: CRD42018079069.
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http://dx.doi.org/10.1136/bmjopen-2020-037674DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7485240PMC
September 2020

More Severe Radiographic Osteoarthritis Is Associated With Increased Improvement in Patients' Health State Following a Total Knee Arthroplasty.

J Arthroplasty 2020 11 17;35(11):3131-3137. Epub 2020 Jun 17.

Department of Orthopaedic Surgery, Lovisenberg Diaconal Hospital, Oslo, Norway.

Background: To assess whether preoperative radiological severity of osteoarthritis (OA) is related to the level of improvement in patients' health state measured 1 year after total knee arthroplasty (TKA).

Methods: Radiographic severity of OA was graded using the Kellgren-Lawrence (KL) classification. Two independent observers were blinded to patients' outcome scores. Health-related quality of life was measured using EQ-5D-3L preoperatively and at 12-month follow-up. The 5 dimensions of the EQ-5D were converted into a health state index score. The association between KL grade and improvement in health state score was analyzed using multiple linear regression.

Results: Among 156 consecutive patients (68% females, mean age 69 years) who underwent primary TKA, 3 knees (2%) were classified as KL grade 2, 115 as KL grade 3 (74%), and 38 as KL grade 4 (24%). Follow-up rate was 77%. There was substantial intra-rater and inter-rater agreement (Cohen's kappa = 0.80 and 0.79). Most patients (64%) had clinically significant improvement in their health state score 1 year after TKA. However, after adjusting for relevant covariates, patients with severe OA (KL grade 4) were found to have significantly more improvement in their health state score than patients with mild or moderate OA (KL grade 2 or 3, respectively). Separate analysis of the 5 EQ-5D dimensions showed that the KL group differences were most evident in the "usual activities" and "pain/discomfort" dimensions.

Conclusion: Patients with severe OA have significantly more improvement in their usual activities and pain/discomfort 1 year after TKA than patients with less severe OA.
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http://dx.doi.org/10.1016/j.arth.2020.06.025DOI Listing
November 2020

High pre- and postoperative symptom burden in non-responders to total knee arthroplasty.

PLoS One 2020 28;15(5):e0233347. Epub 2020 May 28.

Department of Research and Administration, Lovisenberg Diaconal Hospital, Oslo, Norway.

Objectives: One in five patients does not improve in pain with walking (non-responders) 12 months after total knee arthroplasty (TKA). This longitudinal study investigated a broad range of symptoms before and after TKA and evaluated possible differences in symptom distress between responders and non-responders with regards to pain with walking after TKA.

Methods: Prior to TKA surgery, 182 patients completed a demographic questionnaire and the Memorial Symptom Assessment Scale-Short Form (MSAS-SF). The MSAS-SF was repeated 12 months following TKA. Clinical data were extracted from medical records. Patients were categorized as responders or non-responders based on their trajectories of pain with walking assessed prior to surgery, on postoperative day 4, at 6 weeks, and at 3 and 12 months.

Results: Overall, the most distressful preoperative symptoms were pain, lack of energy, difficulty sleeping, feeling drowsy, worrying, feeling bloated, and problems with sexual interest or activity. However, compared with patients classified as responders to TKA, non-responders had higher total symptom distress scores both preoperatively and 12 months postoperatively. Preoperatively, non-responders scored higher than responders on five of the seven most distressing symptoms (i.e., all except difficulty sleeping and feeling bloated), and 12 months postoperatively, non-responders scored higher than responders on six of the seven most distressing symptoms (i.e., all but feeling bloated). In a multivariate analysis, higher preoperative distress scores for pain and problems with sexual interest or activity were significant predictors of non-response to TKA, controlling for other relevant factors.

Conclusions: Patients' preoperative symptom burden may be a useful indicator of their risk for non-improvement following TKA surgery. Future studies need to evaluate the effect of reducing patients' preoperative symptom burden on TKA outcomes.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0233347PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255594PMC
August 2020

Computer-Assisted Compared with Conventional Total Knee Replacement: A Multicenter Parallel-Group Randomized Controlled Trial.

J Bone Joint Surg Am 2018 Aug;100(15):1265-1274

The Norwegian Arthroplasty Register, Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway.

Background: We previously reported the short-term radiographic and functional results of a randomized controlled trial (RCT) comparing computer-assisted and conventionally performed total knee replacement. We currently report the 2-year clinical results from this trial.

Methods: One hundred and ninety patients were randomly allocated to undergo either computer-assisted or conventional total knee replacement. One hundred and seventy-two patients were available for clinical evaluation at 2 years, and 167 (97%) of those answered all patient-reported outcome measures (PROMs), including the Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Society Score (KSS), visual analog scale (VAS), and EuroQol-5 Dimensions (EQ-5D). Patients and clinical evaluators were blinded to the method of surgery. Surgical outcome was assessed using the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) criteria to calculate responder rates, divided into high responders, moderate responders, and nonresponders.

Results: The computer-assisted group had significantly more improvement than the conventional group in the mean scores for 2 subscales of the KOOS (7.4 for symptoms [p = 0.02] and 16.2 for sport and recreation [p < 0.01]) and in 1 subscale of the WOMAC (8.8 for stiffness [p = 0.03]).The computer-assisted group also had significantly more high responders (82.8%) than the conventional group (68.8%; p = 0.03) at 2 years, with the number needed to treat determined to be 8.

Conclusions: In this study, the use of computer navigation provided better pain relief and restored better function than the use of the conventional surgical technique at 2 years after total knee replacement.

Level Of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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http://dx.doi.org/10.2106/JBJS.17.01338DOI Listing
August 2018

Similar migration in computer-assisted and conventional total knee arthroplasty.

Acta Orthop 2017 Apr 20;88(2):166-172. Epub 2016 Dec 20.

b The Norwegian Arthroplasty Register, Department of Orthopaedic Surgery , Haukeland University Hospital , Bergen.

Background and purpose - Computer-assisted surgery (CAS) in total knee arthroplasty (TKA) has been used in recent years in the hope of improving the alignment and positioning of the implant, thereby achieving a better functional outcome and durability. However, the role of computer navigation in TKA is still under debate. We used radiostereometric analysis (RSA) in a randomized controlled trial (RCT) to determine whether there are any differences in migration of the tibial component between CAS- and conventionally (CONV-) operated TKA. Patients and methods - 54 patients (CAS, n = 26; CONV, n = 28) with a mean age of 67 (56-78) years and with osteoarthritis or arthritic disease of the knee were recruited from 4 hospitals during the period 2009-2011. To estimate the mechanical stability of the tibial component, the patients were examined with RSA up to 24 months after operation. The following parameters representing tibial component micromotion were measured: 3-D vector of the prosthetic marker that moved the most, representing the magnitude of migration (maximum total point motion, MTPM); the largest negative value for y-translation (subsidence); the largest positive y-translation (lift-off); and prosthetic rotations. The precision of the RSA measurements was evaluated and migration in the 2 groups was compared. Results - Both groups had most migration within the first 3 months, but there was no statistically significant difference in the magnitude of the migration between the CAS group and the CONV group. From 3 to 24 months, the MTPM (in mm) was 0.058 and 0.103 (p = 0.1) for the CAS and CON groups, respectively, and the subsidence (in mm) was 0.005 and 0.011 (p = 0.3). Interpretation - Mean MTPM, subsidence, lift-off, and rotational movement of tibial trays were similar in CAS- and CONV-operated knees.
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http://dx.doi.org/10.1080/17453674.2016.1267835DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5385111PMC
April 2017

Small and similar amounts of micromotion in an anatomical stem and a customized cementless femoral stem in regular-shaped femurs. A 5-year follow-up randomized RSA study.

Acta Orthop 2014 Apr;85(2):152-8

Orthopaedic Research Centre , Department of Orthopaedic Surgery, Trondheim University Hospital.

Background And Purpose: High primary stability is important for long-term survival of uncemented femoral stems. Different stem designs are currently in use. The ABG-I is a well-documented anatomical stem with a press-fit design. The Unique stem is designed for a tight customized fit to the cortical bone of the upper femur. This implant was initially developed for patients with abnormal anatomy, but the concept can also be used in patients with normal femoral anatomy. We present 5-year radiostereometric analysis (RSA) results from a randomized study comparing the ABG-I anatomical stem with the Unique femoral stem.

Patients And Methods: 100 hips with regular upper femur anatomy were randomized to either the ABG-I stem or the Unique femoral stem. RSA measurements were performed postoperatively and after 3, 6, 12, 24, and 60 months.

Results: RSA measurements from 80 hips were available for analysis at the 5-year follow-up. Small amounts of movement were observed for both stems, with no statistically significant differences between the 2 types.

Interpretation: No improvement in long-term stability was found from using a customized stem design. However, no patients with abnormal geometry of the upper femur were included in this study.
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http://dx.doi.org/10.3109/17453674.2014.899846DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3967257PMC
April 2014

Shortening of an anatomical stem, how short is short enough? An in vitro study of load transfer and primary stability.

Proc Inst Mech Eng H 2013 May 5;227(5):481-9. Epub 2013 Feb 5.

Department of Orthopaedic Surgery, Trondheim University Hospital, Trondheim, Norway.

An anatomical stem should be short enough to avoid distal locking and distal load transfer but long enough to ensure adequate primary stability of the stem. In this in vitro study, the cortical strains in the femur and the primary stability of the stem were measured after insertion of Anatomic Benoist Girard-I anatomical stems with gradually reduced stem length in six human cadaver femurs in order to find the optimal stem length. A shortening of 40-50 mm, corresponding to a stem extending 30-40 mm below the lesser trochanter, did not affect stem stability but nearly normalized the load distribution in the lower metaphysis and upper diaphysis. The large strain shielding observed in the calcar region was not influenced by shortening of the stem.
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http://dx.doi.org/10.1177/0954411912471779DOI Listing
May 2013

A randomized study on migration of the Spectron EF and the Charnley flanged 40 cemented femoral components using radiostereometric analysis at 2 years.

Acta Orthop 2011 Oct 6;82(5):538-44. Epub 2011 Sep 6.

Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway.

Background And Purpose: We performed a randomized study to determine the migration patterns of the Spectron EF femoral stem and to compare them with those of the Charnley stem, which is regarded by many as the gold standard for comparison of implants due to its extensive documentation.

Patients And Methods: 150 patients with a mean age of 70 years were randomized, single-blinded, to receive either a cemented Charnley flanged 40 monoblock, stainless steel, vaquasheen surface femoral stem with a 22.2-mm head (n = 30) or a cemented Spectron EF modular, matte, straight, collared, cobalt-chrome femoral stem with a 28-mm femoral head and a roughened proximal third of the stem (n = 120). The patients were followed with repeated radiostereometric analysis for 2 years to assess migration.

Results: At 2 years, stem retroversion was 2.3° and 0.7° (p < 0.001) and posterior translation was 0.44 mm and 0.17 mm (p = 0.002) for the Charnley group (n = 26) and the Spectron EF group (n = 74), respectively. Subsidence was 0.26 mm for the Charnley and 0.20 mm for the Spectron EF (p = 0.5).

Interpretation: The Spectron EF femoral stem was more stable than the Charnley flanged 40 stem in our study when evaluated at 2 years. In a report from the Norwegian arthroplasty register, the Spectron EF stem had a higher revision rate due to aseptic loosening beyond 5 years than the Charnley. Initial stability is not invariably related to good long-term results. Our results emphasize the importance of prospective long-term follow-up of prosthetic implants in clinical trials and national registries and a stepwise introduction of implants.
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http://dx.doi.org/10.3109/17453674.2011.618914DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3242949PMC
October 2011

Periprosthetic bone loss after insertion of an uncemented, customized femoral stem and an uncemented anatomical stem. A randomized DXA study with 5-year follow-up.

Acta Orthop 2011 Aug 14;82(4):410-6. Epub 2011 Jun 14.

Department of Orthopaedic Surgery, Trondheim University Hospital, Trondheim, Norway.

Background And Purpose: Customized femoral stems are designed to have a perfect fit and fill in the femur in order to achieve physiological load transfer and minimize stress shielding. Dual-energy X-ray absorptiometry (DXA) is regarded as an accurate method for detection of small alterations in bone mineral density (BMD) around hip prostheses. We present medium-term DXA results from a randomized study comparing a customized and an anatomical femoral stem.

Methods: 100 hips were randomized to receive either the anatomical ABG-I stem or the Unique customized femoral stem, both uncemented. DXA measurements were conducted postoperatively and after 3, 6, 12, 24, 36, and 60 months, and BMD was computed for each of the 7 Gruen zones in the proximal femur.

Results: Results from 87 patients were available for analysis. 78 completed the 5-year follow-up: 35 patients in the ABG group and 43 patients in the Unique group. In both groups, we found the greatest degree of bone loss in the proximal Gruen zones. In zone 1, there was 15% reduction in BMD in the ABG-I group and 14% reduction in the Unique group. In zone 7, the reduction was 28% in the ABG-I group and 27% in the Unique group. The only statistically significant difference between the groups was found in Gruen zone 4, which is distal to the tip of the stem, with 1.6% reduction in BMD in the ABG-I group and 9.7% reduction in the Unique group (p = 0.003).

Interpretation: 5-year DXA results showed that because of stress-shielding, proximal bone loss could not be avoided-either for the anatomical ABG-I stem or for the customized Unique stem.
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http://dx.doi.org/10.3109/17453674.2011.588860DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3237029PMC
August 2011

Effect of in-hospital comprehensive geriatric assessment (CGA) in older people with hip fracture. The protocol of the Trondheim Hip Fracture trial.

BMC Geriatr 2011 Apr 21;11:18. Epub 2011 Apr 21.

Department of Geriatrics, St. Olav Hospital, University Hospital of Trondheim, Norway.

Background: Hip fractures in older people are associated with high morbidity, mortality, disability and reduction in quality of life. Traditionally people with hip fracture are cared for in orthopaedic departments without additional geriatric assessment. However, studies of postoperative rehabilitation indicate improved efficiency of multidisciplinary geriatric rehabilitation as compared to traditional care. This randomized controlled trial (RCT) aims to investigate whether an additional comprehensive geriatric assessment of hip fracture patients in a special orthogeriatric unit during the acute in-hospital phase may improve outcomes as compared to treatment as usual in an orthopaedic unit.

Methods/design: The intervention of interest, a comprehensive geriatric assessment is compared with traditional care in an orthopaedic ward. The study includes 401 home-dwelling older persons >70 years of age, previously able to walk 10 meters and now treated for hip fracture at St. Olav Hospital, Trondheim, Norway. The participants are enrolled and randomised during the stay in the Emergency Department. Primary outcome measure is mobility measured by the Short Physical Performance Battery (SPPB) at 4 months after surgery. Secondary outcomes measured at 1, 4 and 12 months postoperatively are place of residence, activities of daily living, balance and gait, falls and fear of falling, quality of life and depressive symptoms, as well as use of health care resources and survival.

Discussion: We believe that the design of the study, the randomisation procedure and outcome measurements will be of sufficient strength and quality to evaluate the impact of comprehensive geriatric assessment on mobility and other relevant outcomes in hip fracture patients.

Trials Registration: ClinicalTrials.gov, NCT00667914.
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http://dx.doi.org/10.1186/1471-2318-11-18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107164PMC
April 2011

Wear and migration of highly cross-linked and conventional cemented polyethylene cups with cobalt chrome or Oxinium femoral heads: a randomized radiostereometric study of 150 patients.

J Orthop Res 2011 Aug 25;29(8):1222-9. Epub 2011 Feb 25.

Department of Orthopaedic Surgery, Haukeland University Hospital, N-5021 Bergen, Norway.

This randomized study was performed to compare wear and migration of five different cemented total hip joint articulations in 150 patients. The patients received either a Charnley femoral stem with a 22.2 mm head or a Spectron EF femoral stem with a 28 mm head. The Charnley articulated with a γ-sterilized Charnley Ogee acetabular cup. The Spectron EF was used with either EtO-sterilized non-cross-linked polyethylene (Reflection All-Poly) or highly cross-linked (Reflection All-Poly XLPE) cups, combined with either cobalt chrome (CoCr) or Oxinium femoral heads. The patients were followed with repeated RSA measurements for 2 years. After 2 years, the EtO-sterilized non-cross-linked Reflection All-Poly cups had more than four times higher proximal penetration than its highly cross-linked counterpart. Use of Oxinium femoral heads did not affect penetration at 2 years compared to heads made of CoCr. Further follow-up is needed to evaluate the benefits, if any, of Oxinium femoral heads in the clinical setting. The Charnley Ogee was not outperformed by the more recently introduced implants in our study. We conclude that this prostheses still represents a standard against which new implants can be measured.
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http://dx.doi.org/10.1002/jor.21389DOI Listing
August 2011

Uncemented custom femoral components in hip arthroplasty. A prospective clinical study of 191 hips followed for at least 7 years.

Acta Orthop 2010 Aug;81(4):427-35

Department of Orthopaedics, St. Olav's University Hospital, Trondheim, Norway.

Background And Purpose: We have developed an individually designed, uncemented femoral component for achievement of improved strain distribution and fixation to the bone, to make uncemented stems more applicable in femurs of abnormal size and shape, and to improve the joint mechanics. Here we describe the design of the implant and present the results of a prospective clinical study with at least 7 years of follow-up.

Patients And Methods: The prostheses are produced by CAD-CAM technique. The design of the stem is based on CT information, and the neck design is based on the surgeon's planning of the center of rotation, femoral head offset, and leg length correction. The first-generation stem produced before 2001 had a proximal HA coating and a sand-blasted distal part that was down-scaled to avoid contact with compact bone. The second-generation stem had a porous coating beneath the HA layer and the distal part of the stem was polished. The implant was used in 762 hips (614 patients) from 1995 until 2009. 191 of these hips were followed for 7 years and 83 others were followed for 10 years, and these hips are included in the present study. Mean age at surgery was 48 (20-65) years. Congenital dysplasia of the hip was the reason for osteoarthritis in 46% and 57% of the hips in respective groups. Merle d'Aubigné score was recorded in 152 and 75 hips in the two groups. Prostheses followed for 10 years, and almost all in the 7-year group, were first-generation stems.

Results: The 7- and 10-year cumulative revision rates were 1.1% and 2.4%, respectively, with stem revision for any reason as endpoint. The clinical results were similar at 7 and 10 years, with Merle d'Aubigné scores of 17. Intraoperative trochanteric fissures occurred in 2 of the 191 operations (1.0%); both healed after wiring. In hips followed for 7 years, 2 periprosthetic fractures occurred; exchange of the stem was necessary in both. One additional fracture occurred between 7 and 10 years, and it was treated successfully with osteosynthesis. The rate of dislocation was 1.6% and 2.4%, respectively. There was no radiographic loosening at follow-up.

Interpretation: Use of a custom femoral stem gives a reliable fixation and promising medium-term clinical results in femurs of normal and abnormal shape and dimension. The individual design, which enables optimized joint mechanics, gives a low risk of mechanical complications.
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http://dx.doi.org/10.3109/17453674.2010.501748DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917564PMC
August 2010

Primary stability of custom and anatomical uncemented femoral stems: a method for three-dimensional in vitro measurement of implant stability.

Clin Biomech (Bristol, Avon) 2010 May 2;25(4):318-24. Epub 2010 Feb 2.

Department of Orthopedic Surgery, Trondheim University Hospital, 7006 Trondheim, Norway.

Background: Lack of primary stability of cementless hip stems prevents bone ingrowth and may lead to loosening of the stem. Direct measures of the implant stability require drilled holes in the bone at the measuring site. These holes weaken the cortical bone, limit the number of possible measuring points and inhibit other biomechanical measurements. This in vitro study aimed to develop a method for indirect measurement of primary stability of femoral stems, leaving the specimen intact. The method was used to compare the primary stability of two uncemented femoral stems with different proximal fit and fill and different stem length.

Methods: An in vitro method for indirect full three-dimensional measurement of implant-bone interface motion was developed. Uncemented customized (n=10) and anatomical stems (n=10) were inserted in human cadaver femora and the primary stability during one leg stance and stair climbing was measured.

Findings: The method had high precision, and the errors due to necessary assumption of rigid body components were minimal. The customized stem with optimal proximal fit and fill provided the best initial stability for rotation in retroversion. The anatomical stem with longer stem length was more resistant to permanent rotation in varus.

Interpretation: During stem design development the primary stability can be measured at all wanted measuring sites with the presented method, leaving the specimen intact for further analyses.
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http://dx.doi.org/10.1016/j.clinbiomech.2009.12.012DOI Listing
May 2010

A clinical and radiographic 13-year follow-up study of 138 Charnley hip arthroplasties in patients 50-70 years old: comparison of university hospital data and registry data.

Acta Orthop 2008 Oct;79(5):609-17

Department of Orthopedic Surgery, Trondheim University Hospital, Trondheim, Norway.

Background And Purpose: Arthroplasty registers provide rates of implant survival in large populations based on implant revision. In an unrevised prosthesis population, some patients may have implants with clinically poor outcome or radiographic failure. We therefore evaluated medium-term clinical and radiographic results in patients with charnley hip arthroplasties and compared our results with data from the Norwegian Arthroplasty Register (NAR).

Patients And Methods: From 1989 through 1991, 138 Charnley arthroplasties with plain Palacos cement were performed in 123 patients who were 50-70 years old. At follow-up after 13 (12-15) years, 26 patients had died (28 hips). The 84 unrevised patients (93 hips) were interviewed and underwent clinical and radiographic assessment. Prosthesis survival was estimated by the Kaplan- Meier method.

Results: At follow-up, 83% of the patients were completely satisfied with their hip replacement. Mean Harris hip score (HHS) was 83 (SD 15), mean EQ-5D index was 0.75 (SD 0.24) and mean EQ-VAS score was 69 (SD 21). Most clinical assessments had poorer scores for Charnley category C (n = 47) than for Charnley category A + B (n = 46). Function, according to Charnley's modified Merle d'Aubigne and Postel scoring system, was improved compared to preoperative values. The survival at 10 years was 89% (95% CI: 84-95) and at 13 years it was 85% (95% CI: 79-92) with revision for any reason as endpoint. In addition to 20 revised hips, 8 implants were radiographically loose and 13 hips had HHS < 70, giving a clinical success rate of 76%. Only 4 primary operations (0.8%) had not been reported to the NAR, but all revisions had been reported.

Interpretation: Clinical follow-up studies give essential information that is additional to that gained from revision-based outcome studies. To fully appreciate the clinical effectiveness of an implant, specific hip function, patient satisfaction, quality of life, and radiographic analysis must also be considered. The functional status of the patient has an important influence on the clinical outcome after hip replacement.
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http://dx.doi.org/10.1080/17453670810016614DOI Listing
October 2008

Improved comfort and function of arm prosthesis after implantation of a Humerus-T-Prosthesis in trans-humeral amputees.

Prosthet Orthot Int 2006 Dec;30(3):270-8

Department of Orthopaedic Surgery, St Olav's University Hospital, Trondheim, Norway.

The use of arm prosthesis in trans-humeral amputees is limited; due to the cone form of the amputation stump. A Humerus-T-Prosthesis was implanted in three patients to create artificial humerus condyles. Two of the patients were successfully rehabilitated with the application of a new type trans-humeral arm prosthesis. This arm prosthesis had a socket which is suspended and stabilized by the humerus and implant only. Traction and rotational stability were secured by adjustable pressure adaptation around the artificial condyles. The third patient developed a pressure wound over the lateral part of the artificial condyle that later healed. He also was subject to a new trauma with a fracture of the ipsilateral scapula and until now has had limited the use of his new arm prosthesis. It was concluded that this new concept for prosthesis fitting of trans-humeral amputees looks promising, but alternative designs of the implant should be tested.
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http://dx.doi.org/10.1080/03093640600605013DOI Listing
December 2006

Differences in stability and bone remodeling between a customized uncemented hydroxyapatite coated and a standard cemented femoral stem A randomized study with use of radiostereometry and bone densitometry.

J Orthop Res 2005 Nov 31;23(6):1280-5. Epub 2005 May 31.

Orthopaedic Centre, Ullevål University Hospital, Kirkeveien 166, N-0407 Oslo, Norway.

The custom made Unique stem is designed to fit closely to the metaphyseal region of the femur in order to obtain maximum mechanical stability and optimal load transfer. Thirty-seven patients (38 hips) with non-inflammatory arthritis were randomized to the uncemented custom made Unique stem or the Elite Plus stem inserted with cement. The patients have been followed clinically as well as with radiostereometry (RSA) and Dual-energy X-ray Absorptiometry (DXA) for 2 years. After 2 years the RSA result showed minimal translation and rotation for the Unique stem while the Elite Plus rotated slightly (mean 1.05 degrees) into retroversion. Compared to previous studies the Elite Plus was as stable as the Charnley prosthesis. The DXA results showed a significantly higher proximal and total (10% for the Unique versus 5% for Elite) bone loss for the Unique stem compared to the Elite Plus. Thus the optimal proximal press-fit of the custom made stem did secure a stable fixation, but did not decrease the proximal bone loss.
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http://dx.doi.org/10.1016/j.orthres.2005.03.016.1100230607DOI Listing
November 2005

Documentation of hip prostheses used in Norway: a critical review of the literature from 1996--2000.

Acta Orthop Scand 2004 Dec;75(6):663-76

Department of Orthopaedic Surgery, Trondheim University Hospital, Trondheim.

We have conducted a systematic review of the scientific literature concerning outcome and clinical effectiveness of prostheses used for primary total hip replacement (THR) in Norway. The study is based on two Health Technology Assessment reports from the UK (Faulkner et al. 1998, Fitzpatrick et al. 1998), reviewing the literature from 1980 to 1995. Using a similar search strategy, we have evaluated the literature from 1996 through 2000. We included 129 scientific and medical publications which were assessed according to a specific appraisal protocol. The majority (72%) were observational studies, whereas only 9% were randomized studies. We could not retrieve any peer-reviewed documentation for one third of the implants. The Charnley prosthesis had by far the best and most comprehensive evidence base with better than 90% implant survival after about 10 years. Survival of the Charnley prosthesis declines by about 10% during each of the two following decades. Except for the Charnley and Lubinus IP, no other prosthesis on the market in Norway has given long-term results (> 15 years). 5 other cemented implants have given comparable results at about 10 years of follow-up. Some uncemented stems have shown promising medium-term outcome, but no combination of uncemented cup and stem fulfilled the benchmark criterion of > or = 90% implant survival at 10 years, which we propose as a minimum requirement for unrestricted clinical use for prostheses used in primary THR. New or undocumented implants should be introduced through a four-step model including preclinical testing, small series evaluated by radiosterometry, randomized clinical trial involving comparison with a well-documented prosthesis, and finally, surveillance of clinical use through registers.
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http://dx.doi.org/10.1080/00016470410004021DOI Listing
December 2004

A quantitative and qualitative analysis of bone remodelling around custom uncemented femoral stems: a five-year DEXA follow-up.

Clin Biomech (Bristol, Avon) 2005 Mar;20(3):277-82

Faculty of Engineering Science and Technology, Department of Structural Engineering, Norwegian University of Science and Technology, Trondheim, Norway.

Background: After total hip replacement bone remodelling is determinant for the implant survival. This study asked whether the immediate postoperative amount and distribution of bone can predict the changes in bone amount and distribution after five years in the case of younger patients with custom uncemented implant.

Methods: We investigated 17 hips with a mean follow-up of 5.1 years. The average patient age at follow-up was 48.5 years. We used immediate postoperative and five-year dual energy X-ray absorptiometry measurements of bone mineral content, density, and projected bone area in seven local zones forming a partition of the upper femur. A correlation was sought between the preoperative variables and the five-year variation. Qualitative bone remodelling was analysed considering each local zone in a density-area plane. Based on geometrical considerations, we introduced an index of structural remodelling, which expresses the preponderance of internal remodelling against external modelling.

Findings: The bone mineral content at operation correlated significantly with its relative decrease locally laterally mid-proximally and medially (P<0.01), distally, and globally for the femur (P<0.05). For the bone mineral density, the correlation was significant distally, medially and globally (P<0.05). The bone projected area shows only significant correlation laterally mid-proximally (P<0.01). The index of structural remodelling was significantly positive (P<0.01) in all local zones and was independent of the initial bone amount and structure (P>0.1).

Interpretation: High bone mineral content at operation correlates significantly with periprosthetic bone loss after five years in younger patients with cementless custom femoral implant. Independently of the net bone mineral content balance, external modelling is stronger than internal remodelling in all local zones.
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http://dx.doi.org/10.1016/j.clinbiomech.2004.10.007DOI Listing
March 2005

External fixation versus locked intramedullary nailing in tibial shaft fractures: a prospective, randomised study of 78 patients.

Arch Orthop Trauma Surg 2005 Feb 21;125(1):21-6. Epub 2004 Dec 21.

Department of Orthopedics, University Hospital, 7006, Trondheim, Norway.

Introduction: We performed a prospective, randomised study to compare the Ex-fi-re external fixator (EF) with locked intramedullary (IM) nailing in tibial fractures. Only fractures without soft-tissue problems of importance were included.

Materials And Methods: Ex-fi-re is a unilateral, dynamic axial fixator with fracture reduction capabilities. The Grosse-Kempf nail was used for nailing. A total of 78 patients with 79 fractures were entered in the study (41 Ex-fi-re, 38 IM nails).

Results: Time to radiographic union and full weight-bearing did not differ significantly, but unprotected weight-bearing was achieved earlier in the IM group (12 vs 20 weeks; p<0.001). There were more reoperations due to secondary dislocation in the EF group. There were no differences in final angulation or shortening. After 6 months and 1 year there were no differences in knee motion, ankle motion, fracture site pain or ankle pain. Some 64% of the nailed patients complained of anterior knee pain after 1 year.

Conclusion: The results were comparable in most respects. Unprotected weight-bearing was achieved earlier after IM nailing. Anterior knee pain was frequent after nailing.
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http://dx.doi.org/10.1007/s00402-004-0768-0DOI Listing
February 2005

High local concentrations without systemic adverse effects after impaction of netilmicin-impregnated bone.

Acta Orthop Scand 2004 Jun;75(3):339-46

Department of Orthopedic Surgery, University Hospital, Trondheim, Norway.

Background: When cancellous bone is impregnated with antibiotics the subsequent release of antibiotics from the bone shows a high early release. Hence, impaction of large amounts of netilmicin-impregnated bone may cause toxic netilmicin values in serum.

Patients And Methods: We studied kidney and otovestibular function after impacting 50 g of netilmicin-impregnated cancellous bone during revision hip or knee arthroplasty in 20 patients. The bone was impacted in the acetabulum (n = 8), proximal femur (n = 9) and distal femur/proximal tibia (n = 3). Serum creatinine concentration was measured and audiometry was performed before and after the operation. Netilmicin concentrations in serum, joint fluid, and in urine were recorded postoperatively at regular intervals. We analyzed pharmacokinetics in two study groups receiving bone impregnated with netilmicin (50 mL), at either 50 mg netilmicin/mL (group I) or 100 mg netilmicin/mL (group II).

Results: Neither netilmicin-induced renal toxicity, nor otovestibular toxicity was registered. Peak serum netilmicin values in group I and group II were 0.9 (0.5-1.3) mg/L and 1.8 (0.6-4.0) mg/L, respectively (p = 0.04). Peak netilmicin concentrations in wound drainage fluid in group I and group II were 237 (9-647) mg/L and 561 (196-1132) mg/L, respectively (p = 0.01). In both groups, netilmicin was recovered in urine samples for approximately 4 weeks.

Interpretation: 50 grams of cancellous bone impregnated with 100 mg/mL netilmicin solution was impacted in the hip or knee joint with no adverse effects. Extremely high local concentrations of netilmicin in joint fluid were recorded postoperatively. The use of antibioitic-impregnated cancellous could be an option when performing revision of hip and knee prostheses.
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http://dx.doi.org/10.1080/00016470410001295DOI Listing
June 2004
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