Minimal important difference, patient acceptable symptom state and longitudinal validity of oxford elbow score and the quickDASH in patients with tennis elbow.

BACKGROUND: The Oxford Elbow Score (OES) and the short version of Disabilities of Arms, Shoulder and Hand (QuickDASH) are common patient-reported outcomes for people with elbow problems. Our primary objective was to define thresholds for the Minimal Important Difference (MID) and Patient-Acceptable Symptom State (PASS) for the OES and QuickDASH. The secondary aim was to compare the longitudinal validity of these outcome measures. METHODS: We recruited 97 patients with clinically-diagnosed tennis elbow for a prospective observational cohort study in a pragmatic clinical setting. Fifty-five participants received no specific intervention, 14 underwent surgery (11 as primary treatment and 4 during follow-up), and 28 received either botulinum toxin injection or platelet rich plasma injection. We collected OES (0 to 100, higher is better) and QuickDASH (0 to 100, higher is worse), and global rating of change (as an external transition anchor question) at six weeks, three months, six months and 12 months. We defined MID and PASS values using three approaches. To assess the longitudinal validity of the measures, we calculated the Spearman's correlation coefficient between the change in the outcome scores and external transition anchor question, and the Area Under the Curve (AUC) from a receiver operating characteristics (ROC) analysis. To assess signal-to-noise ratio, we calculated standardized response means. RESULTS: Depending on the method, MID values ranged from 16 to 21 for OES Pain; 10 to 17 for OES Function; 14 to 28 for OES Social-psychological; 14 to 20 for OES Total score, and - 7 to -9 for QuickDASH. Patient-Acceptable Symptom State (PASS) cut offs were 74 to 84 for OES Pain; 88 to 91 for OES Function; 75 to 78 with OES Social-psychological; 80 to 81 with OES Total score and 19 to 23 with Quick-DASH. OES had stronger correlations with the anchor items, and AUC values suggested superior discrimination (between improved and not improved) compared with QuickDASH. OES also had superior signal-to-noise ratio compared with QuickDASH. CONCLUSION: The study provides MID and PASS values for OES and QuickDASH. Due to better longitudinal validity, OES may be a better choice for clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT02425982 (first registered April 24, 2015).

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.

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.

Outcomes of AO/OTA C-type fractures of the distal humerus after open reduction and internal fixation with locking plate constructs in patients at least 65 years old.

BACKGROUND: Modern treatment options of distal humerus fractures of active elderly patients are osteosynthesis and total elbow arthroplasty. The evidence of outcomes of ORIF after AO/OTA C-type fractures mostly predates the adoption of locking plates. We evaluated the results of open reduction and internal fixation of these fractures treated exclusively with anatomic locking plates. METHODS: A retrospective cohort of 39 patients aged 65 years or above with ORIF for AO/OTA C-type distal humerus fracture using locking plates was analysed. 23 provided follow-up data and 14 attended a follow-up visit. Primary outcome was the Oxford Elbow Score. Secondary outcomes were Mayo Elbow Performance Score, quickDASH, satisfaction, range of motion, complications and revision surgeries. RESULTS: Mean Oxford Elbow Score pain was 83 (SD 17), Oxford Elbow Score function 83 (17) and Oxford Elbow Score social-psychological 79 (20). Mean total Oxford Elbow Score was 81 (15). Among the 14 patients who attended a follow-up visit, Mayo Elbow Performance Score was 85 (17), qDASH 19 (16), active arc of motion 119 (19) degrees. Mayo Elbow Performance Score and arc of motion were worse than on the healthy side. One patient had a serious deep infection. Eleven patients had at least one revision surgery, of which 6 were implant removals and 2 subsequent total elbow arthroplasties. CONCLUSIONS: Distal AO/OTA C-type distal humerus fractures in older adults can be treated reliably and with good outcomes with ORIF using modern locking plates. The mean qDASH scores are similar to population normal values, but when compared to the healthy arm, single-arm outcomes indicated somewhat impaired function. About 1 in 4 patients had at least one revision surgery.

Persistent Tennis Elbow Symptoms Have Little Prognostic Value: A Systematic Review and Meta-analysis.

BACKGROUND: Tennis elbow is a common painful enthesopathy of the lateral elbow that limits upper limb function and frequently results in lost time at work. Surgeons often recommend surgery if symptoms persist despite nonsurgical management, but operations for tennis elbow are inconsistent in their efficacy, and what we know about those operations often derives from observational studies that assume the condition does not continue to improve over time. This assumption is largely untested, and it may not be true; meta-analyzing results from the control arms of tennis elbow studies can help us to evaluate this premise, but to our knowledge, this has not been done. QUESTIONS/PURPOSES: The aims of this systematic review were to describe the course of (1) global improvement, (2) pain, and (3) disability in participants who received no active treatment (placebo or no treatment) in published randomized controlled trials (RCTs) on tennis elbow. We also assessed (4) whether the duration of symptoms or placebo effect is associated with differences in symptom trajectories. METHODS: We searched MEDLINE, Embase, and CENTRAL from database inception to August 12, 2019, for trials including participants with tennis elbow and a placebo or a no-treatment arm and a minimum follow-up duration of 6 months. There were no language restrictions or exclusion criteria. We extracted global improvement, pain, and disability outcomes. We used the Cochrane Risk of Bias tool to assess the risk of bias of included trials. To estimate the typical course of tennis elbow without active treatment, we pooled global improvement (the proportion of participants who reported feeling much better or completely recovered), mean pain, and mean disability using baseline, 1-month, 3-month, 6-month, and 12-month follow-up data. We transformed pain and disability data from the original papers so that at each timepoint the relevant outcome was expressed as change relative to baseline to account for different baseline values. We used meta-regression to assess whether the placebo effect or duration of symptoms before enrollment was associated with differences in symptom trajectories. We included 24 trials with 1085 participants who received no active treatment. RESULTS: The number of patients who were not improved decreased exponentially over time. The half-life of global improvement was between 2.5 and 3 months (that is, every 2.5 to 3 months, 50% of the remaining symptomatic patients reported complete recovery or greatly improved symptoms). At 1 year, 89% (189 of 213; 95% CI 80% to 97%) of patients experienced global improvement. The mean pain and disability followed a similar pattern, halving every 3 to 4 months. Eighty-eight percent of pain (95% CI 70% to 100%) and 85% of disability (95% CI 60% to 100%) had resolved by 1 year. The mean duration of symptoms before trial enrollment was not associated with differences in symptom trajectories. The trajectories of the no-treatment and placebo arms were similar, indicating that the placebo effect of the studied active treatments likely is negligible. CONCLUSION: Based on the placebo or no-treatment control arms of randomized trials, about 90% of people with untreated tennis elbow achieve symptom resolution at 1 year. The probability of resolution appears to remain constant throughout the first year of follow-up and does not depend on previous symptom duration, undermining the rationale that surgery is appropriate if symptoms persist beyond a certain point of time. We recommend that clinicians inform people who are frustrated with persisting symptoms that this is not a cause for apprehension, given that spontaneous improvement is about as likely during the subsequent few months as it was early after the symptoms first appeared. Because of the high likelihood of spontaneous recovery, any active intervention needs to be justified by high levels of early efficacy and little or no risk to outperform watchful waiting. LEVEL OF EVIDENCE: Level I, therapeutic study.

Treatment of hallux rigidus (HARD trial): study protocol of a prospective, randomised, controlled trial of arthrodesis versus watchful waiting in the treatment of a painful osteoarthritic first metatarsophalangeal joint.

INTRODUCTION: Hallux rigidus is a common problem of pain and stiffness of the first metatarsophalangeal joint (MTPJ) caused mainly by degenerative osteoarthritis. Several operative techniques have been introduced for the treatment of this condition without high-quality evidence comparing surgical to non-surgical care. In this trial, the most common surgical procedure, arthrodesis, will be compared with watchful waiting in the management of hallux rigidus. METHODS AND ANALYSIS: Ninety patients (40 years or older) with symptomatic first MTPJ osteoarthritis will be randomised to arthrodesis or watchful waiting in a ratio of 1:1. The primary outcome will be pain during walking, assessed using the 0-10 Numerical Rating Scale (NRS) at 1 year after randomisation. The secondary outcomes will be pain at rest (NRS), physical function (Manchester-Oxford Foot Questionnaire), patient satisfaction in terms of the patient-acceptable symptom state, health-related quality of life (EQ-5D-5L), activity level (The Foot and Ankle Ability Measure Sports subscale), use of analgesics or orthoses and the rate of complications. Our null hypothesis is that there will be no difference equal to or greater than the minimal important difference of the primary outcome measure between arthrodesis and watchful waiting. Our primary analysis follows an intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Committee of Helsinki and Uusimaa Hospital District, Finland. Written informed consent will be obtained from all the participants. We will disseminate the findings of this study through peer-reviewed publications and conference presentations. PROTOCOL VERSION: 21 June 2021 V.2.0. TRIAL REGISTRATION NUMBER: NCT04590313.

Outcomes With Surgery vs Functional Bracing for Patients With Closed, Displaced Humeral Shaft Fractures and the Need for Secondary Surgery: A Prespecified Secondary Analysis of the FISH Randomized Clinical Trial.

IMPORTANCE: Existing evidence indicates that surgery fails to provide superior functional outcome over nonoperative care in patients with a closed humeral shaft fracture. However, up to one-third of patients treated nonoperatively may require secondary surgery. OBJECTIVE: To compare the 2-year outcomes of patients who required secondary surgery with the outcomes of patients with successful initial treatment. DESIGN, SETTING, AND PARTICIPANTS: This 2-year follow-up of the Finnish Shaft of the Humerus (FISH) randomized clinical trial comparing surgery with nonoperative treatment (functional brace) was completed in January 2020. Enrollment in the original trial was between November 2012 and January 2018 at 2 university hospital trauma centers in Finland. A total of 321 adult patients with closed, displaced humeral shaft fracture were assessed for eligibility. After excluding patients with cognitive disabilities, multimorbidity, or multiple trauma and those refusing randomization, 82 patients were randomized. INTERVENTIONS: Interventions were surgery with plate fixation (n = 38; initial surgery group) or functional bracing (n = 44); the latter group was divided into the successful fracture healing group (n = 30; bracing group) and the secondary surgery group (n = 14) with fracture healing problems. MAIN OUTCOMES AND MEASURES: The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 2 years (range, 0 to 100 points; 0 denotes no disability, 100 extreme disability; minimal clinically important difference, 10 points). RESULTS: Of 82 randomized patients, 38 (46%) were female. The mean (SD) age was 48.9 (17.1) years. A total of 74 patients (90%) completed the 2-year follow-up. At 2 years, the mean DASH score was 6.8 (95% CI, 2.3 to 11.4) in the initial surgery group, 6.0 (95% CI, 1.0 to 11.0) in the bracing group, and 17.5 (95% CI, 10.5 to 24.5) in the secondary surgery group. The between-group difference was -10.7 points (95% CI, -19.1 to -2.3; P = .01) between the initial and secondary surgery groups and -11.5 points (95% CI, -20.1 to -2.9; P = .009) between the bracing group and secondary surgery group. CONCLUSIONS AND RELEVANCE: Patients contemplating treatment for closed humeral shaft fracture should be informed that two-thirds of patients treated with functional bracing may heal successfully while one-third may experience fracture healing problems that require secondary surgery and lead to inferior functional outcomes 2 years after the injury. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01719887.

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).

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.

Subacromial decompression surgery for adults with shoulder pain: a systematic review with meta-analysis.

OBJECTIVE: To determine the benefits and harms of subacromial decompression surgery in adult patients with subacromial pain syndrome lasting for more than 3 months. DESIGN: Systematic review with meta-analysis. MAIN OUTCOME MEASURES: Pain, physical function and health-related quality of life. DATA SOURCES: Systematic searches for benefits and harms were conducted to 23 July 2018 in MEDLINE, Embase, PubMed, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Cumulative Index to Nursing and Allied Health Literature, Physiotherapy Evidence Database, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Database of Abstracts of Reviews of Effects, and Health Technology Assessment. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials comparing subacromial decompression surgery for subacromial pain syndrome with any other treatment(s). For harms, we included prospective cohort studies. REVIEW METHODS: Two reviewers independently determined eligibility, extracted the data and assessed the risk of bias of eligible studies. Thirty patients seeking primary or outpatient care for subacromial pain syndrome and a parallel guideline committee (BMJ Rapid Recommendations) provided input regarding systematic review design and interpretation. RESULTS: There was high certainty evidence of no additional benefit of subacromial decompression surgery over placebo surgery in reducing pain at 1 year following surgery (mean difference [MD] -0.26, 95% CI -0.84 to 0.33, minimally important difference [MID] 1.5) or improving physical function at 1-2 years (MD 2.8, 95% CI -1.4 to 6.9, MID 8.3). There was moderate certainty evidence for no additional benefit of subacromial decompression surgery on health-related quality of life at 1 year (MD -0.03 points, 95% CI -0.11 to 0.06, MID 0.07). There was moderate certainty evidence for six serious harms per 1000 (95% CI 5 to 7) patients undergoing subacromial decompression. CONCLUSION: Subacromial decompression surgery provided no important benefit compared with placebo surgery or exercise therapy, and probably carries a small risk of serious harms. SYSTEMATIC REVIEWREGISTRATION NUMBER: CRD42018086862.

Minimal important differences for improvement in shoulder condition patient-reported outcomes: a systematic review to inform a BMJ Rapid Recommendation.

OBJECTIVES: To identify credible anchor-based minimal important differences (MIDs) for patient-reported outcome measures (PROMs) relevant to a BMJ Rapid Recommendations addressing subacromial decompression surgery for shoulder pain. DESIGN: Systematic review. OUTCOME MEASURES: Estimates of anchor-based MIDs, and their credibility, for PROMs judged by the parallel BMJ Rapid Recommendations panel as important for informing their recommendation (pain, function and health-related quality of life (HRQoL)). DATA SOURCES: MEDLINE, EMBASE and PsycINFO up to August 2018. STUDY SELECTION AND REVIEW METHODS: We included original studies of any intervention for shoulder conditions reporting estimates of anchor-based MIDs for relevant PROMs. Two reviewers independently evaluated potentially eligible studies according to predefined selection criteria. Six reviewers, working in pairs, independently extracted data from eligible studies using a predesigned, standardised, pilot-tested extraction form and independently assessed the credibility of included studies using an MID credibility tool. RESULTS: We identified 22 studies involving 5562 patients that reported 74 empirically estimated anchor-based MIDs for 10 candidate instruments to assess shoulder pain, function and HRQoL. We identified MIDs of high credibility for pain and function outcomes and of low credibility for HRQoL. We offered median estimates for the systematic review team who applied these MIDs in Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence summaries and in their interpretations of results in the linked systematic review addressing the effectiveness of surgery for shoulder pain. CONCLUSIONS: Our review provides anchor-based MID estimates, as well as a rating of their credibility, for PROMs for patients with shoulder conditions. The MID estimates inform the interpretation for a linked systematic review and guideline addressing subacromial decompression surgery for shoulder pain, and could also prove useful for authors addressing other interventions for shoulder problems. PROSPERO REGISTRATION NUMBER: CRD42018106531.

Subacromial decompression surgery for adults with shoulder pain: a clinical practice guideline.

CLINICAL QUESTION: Do adults with atraumatic shoulder pain for more than 3 months diagnosed as subacromial pain syndrome (SAPS), also labelled as rotator cuff disease, benefit from subacromial decompression surgery? This guideline builds on to two recent high quality trials of shoulder surgery. CURRENT PRACTICE: SAPS is the common diagnosis for shoulder pain with several first line treatment options, including analgesia, exercises, and injections. Surgeons frequently perform arthroscopic subacromial decompression for prolonged symptoms, with guidelines providing conflicting recommendations. RECOMMENDATION: The guideline panel makes a strong recommendation against surgery. HOW THIS GUIDELINE WAS CREATED: A guideline panel including patients, clinicians, and methodologists produced this recommendation in adherence with standards for trustworthy guidelines and the GRADE system. The recommendation is based on two linked systematic reviews on (a) the benefits and harms of subacromial decompression surgery and (b) the minimally important differences for patient reported outcome measures. Recommendations are made actionable for clinicians and their patients through visual overviews. These provide the relative and absolute benefits and harms of surgery in multilayered evidence summaries and decision aids available in MAGIC (www.magicapp.org) to support shared decisions and adaptation. THE EVIDENCE: Surgery did not provide important improvements in pain, function, or quality of life compared with placebo surgery or other options. Frozen shoulder may be more common with surgery. UNDERSTANDING THE RECOMMENDATION: The panel concluded that almost all informed patients would choose to avoid surgery because there is no benefit but there are harms and it is burdensome. Subacromial decompression surgery should not be offered to patients with SAPS. However, there is substantial uncertainty in what alternative treatment is best.

Nordic Innovative Trials to Evaluate osteoPorotic Fractures (NITEP) Collaboration: The Nordic DeltaCon Trial protocol-non-operative treatment versus reversed total shoulder arthroplasty in patients 65 years of age and older with a displaced proximal humerus fracture: a prospective, randomised controlled trial.

INTRODUCTION: The proximal humerus fracture (PHF) is one of the most common fractures in the elderly. The majority of PHFs are treated non-operatively, while 15%-33% of patients undergo surgical treatment. Recent randomised controlled trial (RCT) and meta-analyses have shown that there is no difference in outcome between non-operative treatment and locking plate or hemi-arthroplasty. During the past decade, reverse total shoulder arthroplasty (RTSA) has gained popularity in the treatment of PHF, although there is a lack of RCTs comparing RTSA to non-operative treatment. METHODS: This is a prospective, single-blinded, randomised, controlled, multicentre and multinational trial comparing RTSA with non-operative treatment in displaced proximal humeral fractures in patients 65-85 years. The primary outcome in this study is QuickDASH-score measured at 2 years. Secondary outcomes include visual analogue scale for pain, grip strength, Oxford shoulder score, Constant score and the number of reoperations and complications.The hypothesis of the trial is that operative treatment with RTSA produces better outcome after 2 and 5 years measured with QuickDASH. ETHICS AND DISSEMINATION: In this protocol, we describe the design, method and management of the Nordic DeltaCon trial. The ethical approval for the trial has been given by the Regional Committee for Medical and Health Research Ethics, Norway. There have been several examples in orthopaedics of innovations that result in failure after medium-term follow-ups . In order to prevent such failures and to increase our knowledge of RSTA, we feel a large-scale study of the effects of the surgery on the outcome that focuses on the complications and reoperations is warranted. After the trial 2-year follow-up, the results will be disseminated in a major orthopaedic publication. TRIAL REGISTRATION NUMBER: NCT03531463; Pre-Results.

Subacromial decompression surgery for rotator cuff disease.

BACKGROUND: Surgery for rotator cuff disease is usually used after non-operative interventions have failed, although our Cochrane Review, first published in 2007, found that there was uncertain clinical benefit following subacromial decompression surgery. OBJECTIVES: To synthesise the available evidence of the benefits and harms of subacromial decompression surgery compared with placebo, no intervention or non-surgical interventions in people with rotator cuff disease (excluding full thickness rotator cuff tears). SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and WHO ICRTP registry from 2006 until 22 October 2018, unrestricted by language. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials (RCTs) of adults with rotator cuff disease (excluding full-thickness tears), that compared subacromial decompression surgery with placebo, no treatment, or any other non-surgical interventions. As it is least prone to bias, subacromial decompression compared with placebo was the primary comparison. Other comparisons were subacromial decompression versus exercises or non-operative treatment. Major outcomes were mean pain scores, shoulder function, quality of life, participant global assessment of success, adverse events and serious adverse events. The primary endpoint for this review was one year. For serious adverse events, we also included data from prospective cohort studies designed to record harms that evaluated subacromial decompression surgery or shoulder arthroscopy. DATA COLLECTION AND ANALYSIS: We used standard methodologic procedures expected by Cochrane. MAIN RESULTS: We included eight trials, with a total of 1062 randomised participants with rotator cuff disease, all with subacromial impingement. Two trials (506 participants) compared arthroscopic subacromial decompression with arthroscopy only (placebo surgery), with all groups receiving postoperative exercises. These trials included a third treatment group: no treatment (active monitoring) in one and exercises in the other. Six trials (556 participants) compared arthroscopic subacromial decompression followed by exercises with exercises alone. Two of these trials included a third arm: sham laser in one and open subacromial decompression in the other.Trial size varied from 42 to 313 participants. Participant mean age ranged between 42 and 65 years. Only two trials reported mean symptom duration (18 to 22 months in one trial and 30 to 31 months in the other), two did not report duration and four reported it categorically.Both placebo-controlled trials were at low risk of bias for the comparison of surgery versus placebo surgery. The other trials were at high risk of bias for several criteria, most notably at risk of performance or detection bias due to lack of participant and personnel blinding. We have restricted the reporting of results of benefits in the Abstract to the placebo-controlled trials.Compared with placebo, high-certainty evidence indicates that subacromial decompression provides no improvement in pain, shoulder function, or health-related quality of life up to one year, and probably no improvement in global success (moderate-certainty evidence, downgraded due to imprecision).At one year, mean pain (on a scale zero to 10, higher scores indicate more pain), was 2.9 points after placebo surgery and 0.26 better (0.84 better to 0.33 worse), after subacromial decompression (284 participants), an absolute difference of 3% (8% better to 3% worse), and relative difference of 4% (12% better to 5% worse). At one year, mean function (on a scale 0 to 100, higher score indicating better outcome), was 69 points after placebo surgery and 2.8 better (1.4 worse to 6.9 better), after surgery (274 participants), an absolute difference of 3% (7% better to 1% worse), and relative difference of 9% (22% better to 4% worse). Global success rate was 97/148 (or 655 per 1000), after placebo and 101/142 (or 708 per 1000) after surgery corresponding to RR 1.08 (95% CI 0.93 to 1.27). Health-related quality of life was 0.73 units (European Quality of Life EQ-5D, -0.59 to 1, higher score indicating better quality of life), after placebo and 0.03 units worse (0.011 units worse to 0.06 units better), after subacromial decompression (285 participants), an absolute difference of 1.3% (5% worse to 2.5% better), and relative difference of 4% (15% worse to 7% better).Adverse events including frozen shoulder or transient minor complications of surgery were reported in approximately 3% of participants across treatment groups in two randomised controlled trials, but due to low event rates we are uncertain if the risks differ between groups: 5/165 (37 per 1000) reported adverse events with subacromial decompression and 9/241 (34 per 1000) with placebo or non-operative treatment, RR 0.91 (95% CI 0.31 to 2.65) (moderate-certainty evidence, downgraded due to imprecision). The trials did not report serious adverse events.Based upon moderate-certainty evidence from two observational trials from the same prospective surgery registry, which also included other shoulder arthroscopic procedures (downgraded for indirectness), the incidence proportion of serious adverse events within 30 days following surgery was 0.5% (0.4% to 0.7%; data collected 2006 to 2011), or 0.6% (0.5 % to 0.7%; data collected 2011 to 2013). Serious adverse events such as deep infection, pulmonary embolism, nerve injury, and death have been observed in participants following shoulder surgery. AUTHORS' CONCLUSIONS: The data in this review do not support the use of subacromial decompression in the treatment of rotator cuff disease manifest as painful shoulder impingement. High-certainty evidence shows that subacromial decompression does not provide clinically important benefits over placebo in pain, function or health-related quality of life. Including results from open-label trials (with high risk of bias) did not change the estimates considerably. Due to imprecision, we downgraded the certainty of the evidence to moderate for global assessment of treatment success; there was probably no clinically important benefit in this outcome either compared with placebo, exercises or non-operative treatment.Adverse event rates were low, 3% or less across treatment groups in the trials, which is consistent with adverse event rates reported in the two observational studies. Although precise estimates are unknown, the risk of serious adverse events is likely less than 1%.

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.

Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort.

INTRODUCTION: Humeral shaft fractures represent 1%-3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly conservative and operative treatment is usually reserved for specific circumstances. To date, no randomised controlled trial (RCT) has compared operative treatment of humeral shaft fractures with conservative treatment. METHODS AND ANALYSIS: We will conduct an RCT to compare the effectiveness and cost-effectiveness of surgical and conservative treatment of humeral shaft fractures. After providing informed consent, 80 patients from 18 years of age with humeral shaft fracture will be randomly assigned to open reduction and internal fixation with locking plate or conservative treatment with functional bracing. We will follow the patients for 10 years and compare the results at different time points. The primary outcome will be Disabilities of Arm, Shoulder and Hand (DASH) at 12 months. The secondary outcomes will include Numerical Rating Scale for pain at rest and in activities, Constant Score and quality of life instrument 15D. Patients not willing to participate in the RCT will be asked to participate in a prospective cohort follow-up study, 'the declined cohort'. This cohort will be followed up at the same time points as the randomised patients to assess the potential effect of participation bias on RCT results and to enhance the external validity of the RCT. In one of the recruiting centres, all cooperative patients with humeral shaft fractures not eligible for randomisation will be asked to participate in a 'non-eligible cohort' study. We will use blinded data interpretation of the randomised cohort to avoid biased interpretation of outcomes. Our null hypothesis is that there is no clinically relevant difference in the primary outcome measure between the two treatment groups. We will consider a difference of a minimum of 10 points in DASH clinically relevant. ETHICS AND DISSEMINATION: The institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings of this study through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT01719887; pre-results.

[Luxatio erecta: two case reports and review of the literature]. / Luxatio erecta--harvinainen vamma koiranulkoiluttajillakin.

Luxatio erecta, inferior dislocation of the glenohumeral joint, is a rare type of injury (1% of shoulder dislocations). In most cases the injury is caused by falling while the upper extremity is hyperabducted. We introduce two cases of consecutive patients with the same rare type of injury--walking the dog. According to the literature, the most frequently used method for the reduction of inferior shoulder dislocation is tractioncountertraction under sedation. If the patient has no other reason to be under general anesthesia or sedation, we recommend, however, administration of local anesthetics and using a less traumatic two-step manoeuvre to reduce inferior shoulder dislocation--luxatio erecta.

Toll-like receptors and aseptic loosening of hip endoprosthesis-a potential to respond against danger signals?

Bacterial remnants and subclinical biofilms residing on prosthesis surfaces have been speculated to play a role in hip implant loosening by opsonizing otherwise relatively inert wear particles. The innate immune system recognizes these microbial pathogen-associated molecular patterns (PAMPs) using Toll-like receptors (TLRs). Our objective was to evaluate the possible presence of TLRs in aseptic synovial membrane-like interface tissue. Bacterial culture-negative, aseptic (n = 4) periprosthetic synovial membrane-like tissue was compared to osteoarthritis synovial membrane (n = 5) for the presence of cells positive for all known human functional TLRs, stained using specific antibodies by immunohistochemistry, and evaluated using morphometry. In comparison to osteoarthtritic synovium, the number of TLR-positive cells was found to be increased in the aseptic setting, reflecting the considerable macrophage infiltration to the tissues investigated. Thus aseptic periprosthetic tissue seems to be very reactive to PAMPs. It has been recently recognized that TLR do not only respond to traditional PAMPs, but also to endogenous alarmings or danger signals released from necrotic and activated cells. Alarming-TLR interaction in the periprosthetic tissue might be a novel mechanism of aseptic loosening of endoprosthesis.