Arthroscopic Partial Meniscectomy for a Degenerative Meniscus Tear Is Not Cost Effective Compared With Placebo Surgery: An Economic Evaluation Based on the FIDELITY Trial Data.

BACKGROUND: In patients with a degenerative tear of the medial meniscus, recent meta-analyses and systematic reviews have shown no treatment benefit of arthroscopic partial meniscectomy (APM) over conservative treatment or placebo surgery. Yet, advocates of APM still argue that APM is cost effective. Giving advocates of APM their due, we note that there is evidence from the treatment of other musculoskeletal complaints to suggest that a treatment may prove cost effective even in the absence of improvements in efficacy outcomes, as it may lead to other benefits, such as diminished productivity loss and reduced costs, and so the question of cost effectiveness needs to be answered for APM. QUESTIONS/PURPOSES: (1) Does APM result in lower postoperative costs compared with placebo surgery? (2) Is APM cost-effective compared with placebo surgery? METHODS: One hundred forty-six adults aged 35 to 65 years with knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis according to the American College of Rheumatology clinical criteria were randomized to APM (n = 70) or placebo surgery (n = 76). In the APM and placebo surgery groups, mean age was 52 ± 7 years and 52 ± 7 years, and 60% (42 of 70) and 62% (47 of 76) of participants were men, respectively. There were no between-group differences in baseline characteristics. In both groups, a standard diagnostic arthroscopy was first performed. Thereafter, in the APM group, the torn meniscus was trimmed to solid meniscus tissue, whereas in the placebo surgery group, APM was carefully mimicked but no resection of meniscal tissue was performed; as such, surgical costs were the same in both arms and were not included in the analyses. All patients received identical postoperative care including a graduated home-based exercise program. At the 2-year follow-up, two patients were lost to follow-up, both in the placebo surgery group. Cost effectiveness over the 2-year trial period was computed as incremental net monetary benefit (INMB) for improvements in quality-adjusted life years (QALY), using both the societal (primary) and healthcare system (secondary) perspectives. To be able to consider APM cost effective, the CEA analysis should yield a positive INMB value. Nonparametric bootstrapping was used to assess uncertainty. Several one-way sensitivity analyses were also performed. RESULTS: APM did not deliver lower postoperative costs, nor did it convincingly improve quality of life scores when compared with placebo surgery. From a societal perspective, APM was associated with € 971 (95% CI -2013 to 4017) higher costs and 0.015 (95% CI -0.011 to 0.041) improved QALYs over 2-year follow-up compared with placebo surgery. Both differences were statistically inconclusive (a wide 95% CI that crossed the line of no difference). Using the conventional willingness to pay (WTP) threshold of € 35,000 per QALY, APM resulted in a negative INMB of € -460 (95% CI -3757 to 2698). In our analysis, APM would result in a positive INMB only when the WTP threshold rises to about € 65,000 per QALY. The wide 95% CIs suggests uncertain cost effectiveness irrespective of chosen WTP threshold. CONCLUSION: The results of this study lend further support to clinical practice guidelines recommending against the use of APM in patients with a degenerative meniscus tear. Given the robustness of existing evidence demonstrating no benefit or cost effectiveness of APM over nonsurgical treatment or placebo surgery, future research is unlikely to alter this conclusion.Level of Evidence Level III, economic analysis.

Minimal important difference and patient acceptable symptom state for common outcome instruments in patients with a closed humeral shaft fracture - analysis of the FISH randomised clinical trial data.

BACKGROUND: Two common ways of assessing the clinical relevance of treatment outcomes are the minimal important difference (MID) and the patient acceptable symptom state (PASS). The former represents the smallest change in the given outcome that makes people feel better, while the latter is the symptom level at which patients feel well. METHODS: We recruited 124 patients with a humeral shaft fracture to a randomised controlled trial comparing surgery to nonsurgical care. Outcome instruments included the Disabilities of Arm, Shoulder, and Hand (DASH) score, the Constant-Murley score, and two numerical rating scales (NRS) for pain (at rest and on activities). A reduction in DASH and pain scores, and increase in the Constant-Murley score represents improvement. We used four methods (receiver operating characteristic [ROC] curve, the mean difference of change, the mean change, and predictive modelling methods) to determine the MID, and two methods (the ROC and 75th percentile) for the PASS. As an anchor for the analyses, we assessed patients' satisfaction regarding the injured arm using a 7-item Likert-scale. RESULTS: The change in the anchor question was strongly correlated with the change in DASH, moderately correlated with the change of the Constant-Murley score and pain on activities, and poorly correlated with the change in pain at rest (Spearman's rho 0.51, -0.40, 0.36, and 0.15, respectively). Depending on the method, the MID estimates for DASH ranged from -6.7 to -11.2, pain on activities from -0.5 to -1.3, and the Constant-Murley score from 6.3 to 13.5. The ROC method provided reliable estimates for DASH (-6.7 points, Area Under Curve [AUC] 0.77), the Constant-Murley Score (7.6 points, AUC 0.71), and pain on activities (-0.5 points, AUC 0.68). The PASS estimates were 14 and 10 for DASH, 2.5 and 2 for pain on activities, and 68 and 74 for the Constant-Murley score with the ROC and 75th percentile methods, respectively. CONCLUSION: Our study provides credible estimates for the MID and PASS values of DASH, pain on activities and the Constant-Murley score, but not for pain at rest. The suggested cut-offs can be used in future studies and for assessing treatment success in patients with humeral shaft fracture. TRIAL REGISTRATION: ClinicalTrials.gov NCT01719887, first registration 01/11/2012.

Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome.

BACKGROUND: The results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that is important to patients. Patient acceptable symptom state (PASS) is a threshold above which patients feel well. OBJECTIVE: To determine MID and PASS for common outcome instruments in patients with subacromial pain syndrome (SAPS). METHODS: We used data from the FIMPACT trial, a randomised controlled trial of treatment for SAPS that included 193 patients. The outcomes were shoulder pain at rest and on arm activity, both measured with the 0-100 mm visual analogue scale (VAS), the Constant-Murley score (CS), and the Simple Shoulder Test (SST). The transition question was a five-point global rating of change. We used three anchor-based methods to determine the MID for improvement: the receiver operating characteristic (ROC) curve, the mean difference of change and the mean change methods. For the PASS, we used the ROC and 75th percentile methods and calculated estimates using two different anchor question thresholds. RESULTS: Different MID methods yielded different estimates. The ROC method yielded the smallest estimates for MID: 20 mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94). We could not establish a reliable MID for pain at rest. The PASS estimates were consistent between methods. The ROC method PASS thresholds using a conservative anchor question threshold were 2 mm for pain at rest, 9 mm for pain on activity, 80 points for CS and 11 points for SST, with AUCs from 0.74 to 0.83. CONCLUSION: We recommend the smallest estimate from different methods as the MID, because it is very unlikely that changes smaller than the smallest MID estimate are important to patients: 20 mm for pain VAS on arm activity, 10 points for CS and 1.5 points for SST. We recommend PASS estimates of 9 mm for pain on arm activity, 80 points for CS, and 11 points for SST. TRIAL REGISTRATION: ClinicalTrials.gov NCT00428870 (first registered January 29, 2007).

Return to work after subacromial decompression, diagnostic arthroscopy, or exercise therapy for shoulder impingement: a randomised, placebo-surgery controlled FIMPACT clinical trial with five-year follow-up.

BACKGROUND: Arthroscopic subacromial decompression is one of the most commonly performed shoulder surgeries in the world. It is performed to treat patients with suspected shoulder impingement syndrome, i.e., subacromial pain syndrome. Only few studies have specifically assessed return-to-work rates after subacromial decompression surgery. All existing evidence comes from open, unblinded study designs and this lack of blinding introduces the potential for bias. We assessed return to work and its predictors in patients with shoulder impingement syndrome in a secondary analysis of a placebo-surgery controlled trial. METHODS: One hundred eighty-four patients in a randomised trial had undergone arthroscopic subacromial decompression (n = 57), diagnostic arthroscopy, a placebo surgical intervention, (n = 59), or exercise therapy (n = 68). We assessed return to work, defined as having returned to work for at least two follow-up visits by the primary 24-month time point, work status at 24 and 60 months, and trajectories of return to work per follow-up time point. Patients and outcome assessors were blinded to the assignment regarding the arthroscopic subacromial decompression vs. diagnostic arthroscopy comparison. We assessed the treatment effect on the full analysis set as the difference between the groups in return-to-work rates and work status at 24 months and at 60 months using Chi-square test and the predictors of return to work with logistic regression analysis. RESULTS: There was no difference in the trajectories of return to work between the study groups. By 24 months, 50 of 57 patients (88%) had returned to work in the arthroscopic subacromial decompression group, while the respective figures were 52 of 59 (88%) in the diagnostic arthroscopy group and 61 of 68 (90%) in the exercise therapy group. No clinically relevant predictors of return to work were found. The proportion of patients at work was 80% (147/184) at 24 months and 73% (124/184) at 60 months, with no difference between the treatment groups (p-values 0.842 and 0.943, respectively). CONCLUSIONS: Arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy or exercise therapy on return to work in patients with shoulder impingement syndrome. We did not find clinically relevant predictors of return to work either. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00428870 .

Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: a 5-year follow-up of a randomised, placebo surgery controlled clinical trial.

OBJECTIVES: To assess the long-term efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy (primary comparison), a placebo surgical intervention, and with a non-operative alternative, exercise therapy (secondary comparison). METHODS: We conducted a multicentre, three group, randomised, controlled superiority trial. We included 210 patients aged 35-65 years, who had symptoms consistent with shoulder impingement syndrome for more than 3 months. 175 participants (83%) completed the 5 years follow-up. Patient enrolment began on 1 February 2005 and the 5-year follow-up was completed by 10 October 2018. The two primary outcomes were shoulder pain at rest and on arm activity measured with Visual Analogue Scale (VAS). Minimally important difference (MID) was set at 15. We used a mixed-model repeated measurements analysis of variance with participant as a random factor, the baseline value as a covariate and assuming a covariance structure with compound symmetry. RESULTS: In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity. There were no between-group differences in the secondary outcomes or adverse events that exceeded the MID. In our secondary comparison (ASD vs exercise therapy), the mean differences between groups (ASD minus exercise therapy) in pain VAS were 1.0 (-5.6 to 7.6; p=0.77) at rest and -3.9 (-12.8 to 5.1; p=0.40) on arm activity. There were no significant between-group differences for the secondary outcomes or adverse events. CONCLUSIONS: ASD provided no benefit over diagnostic arthroscopy (or exercise therapy) at 5 years for patients with shoulder impingement syndrome.

Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial.

OBJECTIVES: To assess the long-term effects of arthroscopic partial meniscectomy (APM) on the development of radiographic knee osteoarthritis, and on knee symptoms and function, at 5 years follow-up. DESIGN: Multicentre, randomised, participant- and outcome assessor-blinded, placebo-surgery controlled trial. SETTING: Orthopaedic departments in five public hospitals in Finland. PARTICIPANTS: 146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised. INTERVENTIONS: APM or placebo surgery (diagnostic knee arthroscopy). MAIN OUTCOME MEASURES: We used two indices of radiographic knee osteoarthritis (increase in Kellgren and Lawrence grade ≥1, and increase in Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score, respectively), and three validated patient-relevant measures of knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale). RESULTS: There was a consistent, slightly greater risk for progression of radiographic knee osteoarthritis in the APM group as compared with the placebo surgery group (adjusted absolute risk difference in increase in Kellgren-Lawrence grade ≥1 of 13%, 95% CI -2% to 28%; adjusted absolute mean difference in OARSI sum score 0.7, 95% CI 0.1 to 1.3). There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively. The corresponding adjusted absolute risk difference in the presence of mechanical symptoms was 18% (95% CI 5% to 31%); there were more symptoms reported in the APM group. All other secondary outcomes comparisons were similar. CONCLUSIONS: APM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 years after surgery. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01052233 and NCT00549172).

Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial.

Importance: Humeral shaft fractures traditionally have been treated nonsurgically, but there has been a steady increase in the rate of surgery over the past 2 decades without high-quality evidence to justify the trend. Objective: To compare the effectiveness of surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing in the treatment of closed humeral shaft fractures. Design, Setting, and Participants: Randomized clinical trial conducted at 2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019. A total of 82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion. Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma. Interventions: Patients were randomly assigned to surgical treatment with open reduction and internal plate fixation (n = 38) or to nonsurgical treatment with functional bracing (n = 44). Main Outcome and Measure: The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 12 months (range, 0 to 100 points, 0 denotes no disability and 100 extreme disability; minimal clinically important difference, 10 points). Results: Among 82 patients who were randomized (mean age, 48.9 years; 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial. Thirteen (30%) of the patients assigned to functional bracing underwent surgery during the 12-month follow-up period to promote healing of the fracture. At 12 months, the mean DASH score was 8.9 (95% CI, 4.2 to 13.6) in the surgery group and 12.0 (95% CI, 7.7 to 16.4) in the bracing group (between-group difference, -3.1 points; 95% CI, -9.6 to 3.3; P = .34). Eleven patients (25%) allocated to functional bracing developed fracture nonunion. Three patients (8%) allocated to surgery developed a temporary radial nerve palsy. Conclusions and Relevance: Among patients with closed humeral shaft fracture, internal fixation surgery, compared with nonoperative functional bracing, did not significantly improve functional outcomes at 12 months. However, the substantial amount of treatment crossover from nonoperative to surgical treatment should be considered when interpreting the trial results. Trial Registration: ClinicalTrials.gov Identifier: NCT01719887.

Five-Year Follow-Up of Surgery vs Functional Bracing for Closed Displaced Humeral Shaft Fractures.

This study compares outcomes of surgery and functional bracing for closed humeral shaft fractures after 5 years of follow-up.

Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear: a 2-year follow-up of the randomised controlled trial.

OBJECTIVE: To assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus. METHODS: In this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35-65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out. RESULTS: In the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, -4.3; 95% CI, -11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (-3.2; -8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (-0.4; -1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups. CONCLUSIONS: In this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.

Treatment after traumatic shoulder dislocation: a systematic review with a network meta-analysis.

OBJECTIVE: To review and compare treatments (1) after primary traumatic shoulder dislocation aimed at minimising the risk of chronic shoulder instability and (2) for chronic post-traumatic shoulder instability. DESIGN: Intervention systematic review with random effects network meta-analysis and direct comparison meta-analyses. DATA SOURCES: Electronic databases (Ovid MEDLINE, Cochrane Clinical Trials Register, Cochrane Database of Systematic Reviews, Embase, Scopus, CINAHL, Ovid MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily, DARE, HTA, NHSEED, Web of Science) and reference lists were searched from inception to 15 January 2018. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised trials comparing any interventions either after a first-time, traumatic shoulder dislocation or chronic post-traumatic shoulder instability, with a shoulder instability, function or quality of life outcome. RESULTS: Twenty-two randomised controlled trials were included. There was moderate quality evidence suggesting that labrum repair reduced the risk of future shoulder dislocation (relative risk 0.15; 95% CI 0.03 to 0.8, p=0.026), and that with non-surgical management 47% of patients did not experience shoulder redislocation. Very low to low-quality evidence suggested no benefit of immobilisation in external rotation versus internal rotation. There was low-quality evidence that an open procedure was superior to arthroscopic surgery for preventing shoulder redislocations. CONCLUSIONS: There was moderate-quality evidence that half of the patients managed with physiotherapy after a first-time traumatic shoulder dislocation did not experience recurrent shoulder dislocations. If chronic instability develops, surgery could be considered. There was no evidence regarding the effectiveness of surgical management for post-traumatic chronic shoulder instability.

Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear.

BACKGROUND: Arthroscopic partial meniscectomy is one of the most common orthopedic procedures, yet rigorous evidence of its efficacy is lacking. METHODS: We conducted a multicenter, randomized, double-blind, sham-controlled trial in 146 patients 35 to 65 years of age who had knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis. Patients were randomly assigned to arthroscopic partial meniscectomy or sham surgery. The primary outcomes were changes in the Lysholm and Western Ontario Meniscal Evaluation Tool (WOMET) scores (each ranging from 0 to 100, with lower scores indicating more severe symptoms) and in knee pain after exercise (rated on a scale from 0 to 10, with 0 denoting no pain) at 12 months after the procedure. RESULTS: In the intention-to-treat analysis, there were no significant between-group differences in the change from baseline to 12 months in any primary outcome. The mean changes (improvements) in the primary outcome measures were as follows: Lysholm score, 21.7 points in the partial-meniscectomy group as compared with 23.3 points in the sham-surgery group (between-group difference, -1.6 points; 95% confidence interval [CI], -7.2 to 4.0); WOMET score, 24.6 and 27.1 points, respectively (between-group difference, -2.5 points; 95% CI, -9.2 to 4.1); and score for knee pain after exercise, 3.1 and 3.3 points, respectively (between-group difference, -0.1; 95% CI, -0.9 to 0.7). There were no significant differences between groups in the number of patients who required subsequent knee surgery (two in the partial-meniscectomy group and five in the sham-surgery group) or serious adverse events (one and zero, respectively). CONCLUSIONS: In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure. (Funded by the Sigrid Juselius Foundation and others; ClinicalTrials.gov number, NCT00549172.).

Elevated risk of early reoperation in total hip replacement during the stage of unit closure: A population-based registry study of total hip and knee replacements in Finland, 1998-2011.

BACKGROUND AND PURPOSE: The effects of launch or closure of an entire arthroplasty unit on the first or last patients treated in these units have not been studied. Using a 3-year follow-up, we investigated whether patients who were treated at the launch or closure stage of an arthroplasty unit of a hospital would have a higher risk of reoperation than patients treated in-between at the same units. PATIENTS AND METHODS: From the Finnish Arthroplasty Register, we identified all the units that had performed total joint arthroplasty and the units that were launched or closed in Finland between 1998 and 2011. The risks of reoperation within 3 years for the 41,748 total hip and knee replacements performed due to osteoarthritis in these units were modeled with Cox proportional-hazards regression, separately for hip and knee and for the launch and the closure stage. RESULTS: The unadjusted and adjusted hazard ratios (HRs) for total hip and knee replacements performed in the initial stage of activity of the units that were launched were similar to the reoperation risks in patients who were operated in these units after the early stage of activity. The unadjusted and risk-adjusted HRs for early reoperation after total hip replacement (THR) were increased at the closure stage (adjusted HR = 1.8, 95% CI: 1.2-2.8). The reoperation risk at the closure stage after total knee replacement (TKR) was not increased. INTERPRETATION: The results indicate that closure of units performing total hip replacements poses an increased risk of reoperation. Closures need to be managed carefully to prevent the quality from deteriorating when performing the final arthroplasties.

Treatment of proximal humerus fractures in the elderly: a systemic review of 409 patients.

BACKGROUND AND PURPOSE: There is no consensus on the treatment of proximal humerus fractures in the elderly. PATIENTS AND METHODS: We conducted a systematic search of the medical literature for randomized controlled trials and controlled clinical trials from 1946 to Apr 30, 2014. Predefined PICOS criteria were used to search relevant publications. We included randomized controlled trials involving 2- to 4-part proximal humerus fractures in patients over 60 years of age that compared operative treatment to any operative or nonoperative treatment, with a minimum of 20 patients in each group and a minimum follow-up of 1 year. Outcomes had to be assessed with functional or disability measures, or a quality-of-life score. RESULTS: After 2 independent researchers had read 777 abstracts, 9 publications with 409 patients were accepted for the final analysis. No statistically significant differences were found between nonoperative treatment and operative treatment with a locking plate for any disability, for quality-of-life score, or for pain, in patients with 3- or 4-part fractures. In 4-part fractures, 2 trials found similar shoulder function between hemiarthroplasty and nonoperative treatment. 1 trial found slightly better health-related quality of life (higher EQ-5D scores) at 2-year follow-up after hemiarthroplasty. Complications were common in the operative treatment groups (10-29%). INTERPRETATION: Nonoperative treatment over locking plate systems and tension banding is weakly supported. 2 trials provided weak to moderate evidence that for 4-part fractures, shoulder function is not better with hemiarthroplasty than with nonoperative treatment. 1 of the trials provided limited evidence that health-related quality of life may be better at 2-year follow-up after hemiarthroplasty. There is a high risk of complications after operative treatment.

Hip prosthesis introduction and early revision risk. A nationwide population-based study covering 39,125 operations.

BACKGROUND AND PURPOSE: Little is known about the effect of the learning curve for different types of total hip arthroplasties (THAs). We investigated the prostheses survival of THAs just after the implementation of a model new to the hospital, and compared these results with the results of THAs done when more than 100 implantations had been undertaken. In addition, we investigated whether differences exist between different types of femoral stems and acetabular cups at the early implementation phase. PATIENTS AND METHODS: We used comprehensive registry data from all units (n = 76) that performed THAs for primary osteoarthritis in Finland between 1998 and 2007. Complete data including follow-up data to December 31, 2010 or until death were available for 33,819 patients (39,125 THAs). The stems and cups used were given order numbers in each hospital and classified into 5 groups: operations with order number (a) 1-15, (b) 16-30, (c) 31-50, (d) 51-100, and (e) > 100. We used Cox's proportional hazards modeling for calculation of the adjusted hazard ratios for the risk of revision during the 3 years following the implementation of a new THA endoprosthesis type in the groups. RESULTS: Introduction of new endoprosthesis types was common, as more than 1 in 7 patients received a type that had been previously used in 15 or less operations. For the first 15 operations after a stem or cup type was introduced, there was an elevated risk of revision (hazard ratio (HR) = 1.3, 95% CI: 1.1-1.5). There were differences in the risk of early revision between stem and cup types at implementation. INTERPRETATION: The first 15 operations with a new stem or cup model had an increased risk of early revision surgery. Stems and cups differed in their early revision risk, particularly at the implementation phase. Thus, the risk of early revision at the implementation phase should be considered when a new type of THA is brought into use.

Surgical treatment of Rockwood grade-V acromioclavicular joint dislocations: 50 patients followed for 15­22 years.

BACKGROUND AND PURPOSE: Long-term outcome after surgery for grade-V acromioclavicular joint dislocation has not been reported. We performed a retrospective analysis of functional and radiographic outcome 15-22 years after surgery. PATIENTS AND METHODS: We examined 50 patients who were treated at our hospital between April 1985 and December 1993. Various methods of stabilization were used: K-wires (n = 36), 4.5-mm screw (n = 12), or biodegradable screw (n = 2). Osteosynthesis material was removed after 6-8 weeks. Mean follow-up time was 18 (15-22) years. Outcomes were assessed with the Constant shoulder (CS) score, Disabilities of the Arm, Shoulder, and Hand (DASH) score, the simple shoulder test (SST), the Copeland shoulder impingement test, the cross-arm test, pain, stability of the AC joint, and complications. From radiographs, we evaluated AC and glenohumeral (GH) arthrosis, osteolysis of the lateral clavicle, and alignment of the clavicle with the acromion. RESULTS: Mean values were 90 (75-100) in CS score, 5.1 (0-41) in DASH score, and 11 (2-12) in SST. There was no statistically significant difference in CS score between the injured shoulder and the uninjured shoulder. The AC joint was clinically stable in 42 patients. In 38 patients, the clavicle alignment with the acromion was normal in radiographs. Lateral clavicle osteolysis (10 patients) appeared to be associated with permanent AC joint dislocation. INTERPRETATION: Surgery with a temporary fixation for acute grade-V AC joint dislocation leads to successful long-term functional results. Only minor disability occurred in some patients.

Outcomes at a Mean of 13 Years After Proximal Humeral Fracture During Adolescence.

BACKGROUND: The long-term outcomes of a proximal humeral fracture during adolescence are not well known. We investigated the course of primary treatment for these injuries and the long-term outcomes in adulthood, comparing the outcomes with those from age-matched controls. We also compared outcomes after operative and nonoperative treatment via propensity score matching. METHODS: We included children who sustained a proximal humeral fracture between the ages of 10.0 and 16.0 years and underwent treatment between 1995 and 2005. Data from primary treatment episodes were extracted from patient files. The patients were invited to a follow-up visit with outcome assessment and radiographs or to a telephone interview if unable to attend. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The secondary outcomes were the Simple Shoulder Test (SST), pain at rest and with strenuous use, shoulder range of motion, strength measurements, health-related quality of life (15D), and harms. Participant results were compared with the normal values of an age-matched population. The effect of operative treatment was assessed using propensity score matching and the average treatment effect was calculated. RESULTS: This study included 209 patients (210 fractures). The mean follow-up (and standard deviation) was 13.1 ± 3.2 years. Outcome data were obtained from 152 participants (153 fractures); 78 participants attended the follow-up visit. The primary treatment episodes were uneventful. The mean scores were 2.5 (95% confidence interval [CI], 1.8 to 3.3 [range, 0 to 13]) for the DASH and 11.7 (95% CI, 11.5 to 11.8 [range, 8 to 12]) for the SST. Other outcomes were similarly good. There were no differences in function compared with the normal population values. Propensity matching showed no treatment effect for operative treatment compared with nonoperative treatment. CONCLUSIONS: Proximal humeral fractures of adolescents heal well and rarely result in impairments whether treated operatively or nonoperatively. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Concordance of shoulder symptoms and imaging findings: a protocol for the Finnish Imaging of Shoulder (FIMAGE) study.

INTRODUCTION: Shoulder pain is a substantial medical and socioeconomic problem in most societies, affecting the ability to work or carry out leisure time activities as well as subsequently influencing physical and psychological well-being. According to a nationwide survey in Finland, 27% of the population reported shoulder pain within the last 30 days. In clinical practice, imaging findings of structural abnormalities are typically thought to explain symptoms, even though such findings are also prevalent in asymptomatic individuals, particularly with increasing age. Overall, there is a paucity of high-quality evidence on the prevalence, clinical relevance and prognosis of 'abnormal' imaging findings of the shoulder.The aim of the Finnish Imaging of Shoulder (FIMAGE) study is fourfold: to assess (1) the prevalence of shoulder symptoms and the most common anatomical variants and imaging abnormalities of the shoulder; (2) the concordance between shoulder symptoms, function and imaging abnormalities; (3) the most important determinants of symptoms, function and imaging abnormalities; and (4) the course of shoulder complaints over 5 years. METHODS: The FIMAGE target population of 600 participants, aged 40-75 years, will be randomly selected from a nationally representative general population sample of 9922 individuals originally recruited for the Finnish Health 2000 Survey. On giving informed consent, the participants will be invited to a clinical visit that includes assessment of general health, shoulder symptoms, bilateral shoulder examination and imaging of both shoulders with plain radiography and MRI. ETHICS AND DISSEMINATION: The study has been approved by the Institutional Review Board of the Helsinki and Uusimaa Hospital District. The findings will be published according to the Strengthening the Reporting of Observational Studies in Epidemiology criteria. TRIAL REGISTRATION NUMBER: NCT05641415.

Introducing a knee endoprosthesis model increases risk of early revision surgery.

BACKGROUND: New equipment and techniques often are used in clinical practice, occasionally without evidence of effectiveness and safety. QUESTIONS/PURPOSES: We asked whether the stage of introduction of an endoprosthesis model for TKA affected the risk of early revision. METHODS: We studied mandatory registry data from all centers in Finland (n = 69) that performed TKAs for primary osteoarthritis between 1998 and 2004. Of the total of 23,707 patients (28,760 TKAs), 22,551 patients (27,105 TKAs) had a followup of 5 years; we excluded longer followup from the analysis as subsequent revisions might result from wear rather than early technical failures. We used proportional hazards modeling for calculating the hazard ratios for the first 15 operations and subsequent increments of numbers of operations while adjusting for potentially confounding variables. RESULTS: For the first 15 operations with a new endoprosthesis, the risk was elevated (hazard ratio, 1.48; 95% confidence interval, 1.14-1.91). Absolute risk increase of early revision for the first 15 patients was 1.7% (95% confidence interval, 0.7-2.7). The risk was not increased as the numbers of TKAs incrementally performed increased. CONCLUSIONS: Our data show an increased risk of early revision surgery for the first patients obtaining a knee endoprosthesis model previously unused in the hospital. Patients should be informed if there is a plan to introduce a new model of endoprosthesis in the hospital and offered the possibility to choose a conventional endoprosthesis instead. Although introducing potentially better endoprostheses is important, there is a need for managed introduction of new technology. LEVEL OF EVIDENCE: Level I, prognostic study. See the Guidelines for Authors for a complete description of levels of evidence.

Arthrosis of glenohumeral joint after arthroscopic Bankart repair: a long-term follow-up of 13 years.

HYPOTHESIS: The purpose of the study was to establish radiologic and clinical occurrence of glenohumeral arthrosis after arthroscopic Bankart repair. MATERIALS AND METHODS: Between January 1994 and December 1998, an arthroscopic Bankart repair was performed in 187 patients at our institution. We were able to assess clinical and radiologic glenohumeral arthrosis in 72 of the 101 patients who met the inclusion criteria (74 shoulders) (71%) after a 13-year follow-up. An additional 9 patients were interviewed by telephone. Radiologic arthrosis was evaluated with the Samilson-Prieto classification and clinical arthrosis with an arthrosis-specific quality-of-life questionnaire (Western Ontario Osteoarthritis of the Shoulder test). In addition, functional impairment was assessed with the Constant score and subjective satisfaction with a questionnaire. RESULTS: Radiologic arthrosis was diagnosed in 50 of 74 shoulders (68%), with 40 (80%) of them classified as mild. The mean score on the Western Ontario Osteoarthritis of the Shoulder questionnaire was 280 points (85% of the best possible score), which is considered relatively good. The mean Constant score was 78 points, and 75% of the patients were extremely satisfied or satisfied with the final results of operative treatment. DISCUSSION: The radiologic evaluation and self-assessment of the patients imply that the incidence of glenohumeral arthrosis after arthroscopic Bankart repair is quite common but the symptoms are generally mild and comparable to nonoperative treatment. CONCLUSION: Arthrosis rarely causes more than minor subjective symptoms or a minor objectively perceived disadvantage during 13 years' follow-up.

Operative and nonoperative treatment of clavicle fractures in adults.

BACKGROUND AND PURPOSE: Traditionally, clavicle fractures have been treated nonoperatively. However, many recent studies have concentrated on the results of operative treatment. We assessed and compared the outcomes of operative and nonoperative treatment for acute clavicle fractures in adults. METHODS: We performed a systematic search of the medical literature from 1966 until the end of March 2011. We included randomized controlled trials and controlled clinical trials comparing operative and nonoperative treatment and studies comparing different operative and nonoperative treatments. We required that there should be at least 30 adult patients and a follow-up of at least 6 months in each individual trial. We used the GRADE method to assess the quality of evidence. RESULTS: 6 randomized controlled trials (n = 631) and 7 controlled clinical trials (n = 559) were included. There was moderate-quality evidence (i.e. of grade B) (1) that surgery has considerable effectiveness on better function and less disability at short follow-up, (2) of similar risk of relatively mild complications after operative or nonoperative treatment, (3) that delayed union and nonunion were more common in patients who were treated nonoperatively than in those treated operatively, and (4) that the osteosynthesis method had no effect on the incidence of delayed union or nonunion. Only 1 controlled clinical trial was found on lateral clavicle fractures with very limited (grade D) evidence. INTERPRETATION: Patients treated operatively have slightly better function and less disability than those treated nonoperatively at short follow-up, but then the effectiveness diminishes and is weak at 6 months. The different operative techniques may not differ in effectiveness or in adverse effects, but the evidence is very limited or conflicting. Surgery could be considered for active patients who require recovery to the previous level of activity in the shortest possible time.