The potential value of observational studies of elective surgical interventions using routinely collected data.

PURPOSE: To assess the apparent validity of observational studies of elective arthroplasty interventions. METHODS: Data from the nationwide Dutch Arthroplasty Register were used. The first case study compared surgical approaches for total hip arthroplasty (posterolateral approach vs. straight lateral approach), where allocation of the intervention was assumed to be mostly independent of patient characteristics. The second case study compared fixation methods (cemented vs. uncemented), where choice of fixation method was expected to depend on patient characteristics. The potential for confounding was quantified by differences between intervention groups and the impact of confounding adjustment. RESULTS: The study of posterolateral approach versus straight lateral approach included 73,750 and 16,557 patients, respectively, and showed no meaningful differences in patient characteristics between treatment groups (standardized mean differences <0.1) and also no relevant impact of confounding adjustment (Z-scores <1). The study of cemented versus uncemented total hip arthroplasty (THA) included 29,579 and 79,360 patients, respectively. Several meaningful imbalances were observed in patient characteristic between the two treatment groups (standardized mean differences >0.1), as well as a relevant impact of confounding adjustment (Z-scores >2). CONCLUSIONS: This study provides insight in the reasoning behind the credibility of observational studies of surgical interventions using routinely collected data and when confounding is expected to have a major impact and thus additional precautions to limit confounding are needed.

Let's Agree to Disagree on Operative versus Nonoperative (LADON) treatment for proximal humerus fractures: Study protocol for an international multicenter prospective cohort study.

BACKGROUND: The proximal humerus fracture is a common injury, but the optimal management is much debated. The decision for operative or nonoperative treatment is strongly influenced by patient specific factors, regional and cultural differences and the preference of the patient and treating surgeon. The aim of this study is to compare operative and nonoperative treatment of proximal humerus fractures for those patients for whom there is disagreement about optimal management. METHODS AND ANALYSIS: This protocol describes an international multicenter prospective cohort study, in which all patients of 18 years and older presenting within three weeks after injury with a radiographically diagnosed displaced proximal humerus fracture can be included. Based on patient characteristics and radiographic images several clinical experts advise on the preferred treatment option. In case of disagreement among the experts, the patient can be included in the study. The actual treatment that will be delivered is at the discretion of the treating physician. The primary outcome is the QuickDash score at 12 months. Propensity score matching will be used to control for potential confounding of the relation between treatment modality and QuickDash scores. DISCUSSION: The LADON study is an international multicenter prospective cohort study with a relatively new methodological study design. This study is a "natural experiment" meaning patients receive standard local treatment and surgeons perform standard local procedures, therefore high participation rates of patients and surgeons are expected. Patients are only included after expert panel evaluation, when there is proven disagreement between experts, which makes this a unique study design. Through this inclusion process, we create two comparable groups whom received different treatments and where expert disagree about the already initiated treatment. Since we are zooming in on this particular patient group, confounding will be largely mitigated. Internationally the treatment of proximal humerus fractures are still much debated and differs much per country and hospital. This observational study with a natural experiment design will create insight into which treatment modality is to be preferred for patients in whom there is disagreement about the optimal treatment strategy. TRIAL REGISTRATION: Registered in Netherlands trial register NL9357 and Swiss trial register CH 2020-00961; https://clinicaltrials.gov/.

Validation of PROMIS Physical Function for Evaluating Outcome After Acute Achilles Tendon Rupture.

BACKGROUND: There is increased demand for valid, reliable, and responsive patient-reported outcome measures (PROMs) to evaluate treatment for Achilles tendon rupture, but not all PROMs currently in use are reliable and responsive for this condition. PURPOSE: To evaluate the measurement properties of the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) compared with other PROMs used after treatment for acute Achilles tendon rupture. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 2. METHODS: A retrospective cohort study with a follow-up questionnaire was performed. All adult patients with an acute Achilles tendon rupture between June 2016 and June 2018 with a minimum 12-month follow-up were eligible for inclusion. Functional outcome was assessed using the PROMIS PF computerized adaptive test (CAT), Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL), FAAM-Sports, and Achilles Tendon Total Rupture Score (ATRS). Pearson correlation (r) was used to assess the correlations between PROMs. Absolute and relative floor and ceiling effects were calculated. RESULTS: In total, 103 patients were included (mean age, 44.7 years; 74% male); 82 patients (79.6%) underwent operative repair, while 21 patients (20.4%) underwent nonoperative management. The mean time between treatment and collection of PROMs was 25.3 months (range, 15-36 months). The mean scores were 55.4 ± 9.2 (PROMIS PF), 92.9 ± 12.2 (FAAM-ADL), 77.7 ± 22.9 (FAAM-Sports), and 83.0 ± 19.4 (ATRS). The ATRS was correlated with FAAM-ADL (r = 0.80; 95% CI, 0.72-0.86; P < .001) and FAAM-Sports (r = 0.86; 95% CI, 0.80-0.90; P < .001). The PROMIS PF was correlated with the FAAM-ADL (r = 0.66; 95% CI, 0.53-0.75; P < .001), FAAM-Sports (r = 0.65; 95% CI, 0.53-0.75; P < .001), and ATRS (r = 0.69; 95% CI, 0.58-0.78; P < .001). The PROMIS PF did not show absolute floor or ceiling effects (0%). The FAAM-ADL (35.9%), FAAM-Sports (15.8%), and ATRS (20.4%) had substantial absolute ceiling effects. CONCLUSION: The PROMIS PF, FAAM-ADL, and FAAM-Sports all showed a moderate to high mutual correlation with the ATRS. Only the PROMIS PF avoided substantial floor and ceiling effects. The results suggest that the PROMIS PF CAT is a valid, reliable, and perhaps the most responsive tool to evaluate patient outcomes after treatment for an Achilles tendon rupture.

In-house versus on-call trauma surgeon coverage: A systematic review and meta-analysis.

BACKGROUND: A rapid trauma response is essential to provide optimal care for severely injured patients. However, it is currently unclear if the presence of an in-house trauma surgeon affects this response during call and influences outcomes. This study compares in-hospital mortality and process-related outcomes of trauma patients treated by a 24/7 in-house versus an on-call trauma surgeon. METHODS: PubMed/Medline, Embase, and CENTRAL databases were searched on the first of November 2020. All studies comparing patients treated by a 24/7 in-house versus an on-call trauma surgeon were considered eligible for inclusion. A meta-analysis of mortality rates including all severely injured patients (i.e., Injury Severity Score of ≥16) was performed. Random-effect models were used to pool mortality rates, reported as risk ratios. The main outcome measure was in-hospital mortality. Process-related outcomes were chosen as secondary outcome measures. RESULTS: In total, 16 observational studies, combining 64,337 trauma patients, were included. The meta-analysis included 8 studies, comprising 7,490 severely injured patients. A significant reduction in mortality rate was found in patients treated in the 24/7 in-house trauma surgeon group compared with patients treated in the on-call trauma surgeon group (risk ratio, 0.86; 95% confidence interval, 0.78-0.95; p = 0.002; I2 = 0%). In 10 of 16 studies, at least 1 process-related outcome improved after the in-house trauma surgeon policy was implemented. CONCLUSION: A 24/7 in-house trauma surgeon policy is associated with reduced mortality rates for severely injured patients treated at level I trauma centers. In addition, presence of an in-house trauma surgeon during call may improve process-related outcomes. This review recommends implementation of a 24/7 in-house attending trauma surgeon at level I trauma centers. However, the final decision on attendance policy might depend on center and region-specific conditions. LEVEL OF EVIDENCE: Systematic review/meta-analysis, level III.

Traumatic rib fractures: a marker of severe injury. A nationwide study using the National Trauma Data Bank.

BACKGROUND: In recent years, there has been increasing interest in the treatment of patients with rib fractures. However, the current literature on the epidemiology and outcomes of rib fractures is outdated and inconsistent. Furthermore, although it has been suggested that there is a large heterogeneity among patients with traumatic rib fractures, there is insufficient literature reporting on the outcomes of different subgroups. METHODS: A retrospective cohort study using the National Trauma Data Bank was performed. All adult patients with one or more traumatic rib fractures or flail chest who were admitted to a hospital between January 2010 and December 2016 were identified by the International Classification of Diseases Ninth Revision diagnostic codes. RESULTS: Of the 564 798 included patients with one or more rib fractures, 44.9% (n=2 53 564) were patients with polytrauma. Two per cent had open rib fractures (n=11 433, 2.0%) and flail chest was found in 4% (n=23 388, 4.1%) of all cases. Motor vehicle accidents (n=237 995, 51.6%) were the most common cause of rib fractures in patients with polytrauma and flail chest. Blunt chest injury accounted for 95.5% (n=5 39 422) of rib fractures. Rib fractures in elderly patients were predominantly caused by high and low energy falls (n=67 675, 51.9%). Ultimately, 49.5% (n=2 79 615) of all patients were admitted to an intensive care unit, of whom a quarter (n=146 191, 25.9%) required invasive mechanical ventilatory support. The overall mortality rate was 5.6% (n=31 524). DISCUSSION: Traumatic rib fractures are a marker of severe injury as approximately half of patients were patients with polytrauma. Furthermore, patients with rib fractures are a very heterogeneous group with a considerable difference in epidemiology, injury characteristics and in-hospital outcomes. Worse outcomes were predominantly observed among patients with polytrauma and flail chest. Future studies should recognize these differences and treatment should be evaluated accordingly. LEVEL OF EVIDENCE: II/III.

Association of Patient-reported Outcomes With Clinical Outcomes After Distal Humerus Fracture Treatment.

In this study, we assessed the patient-reported outcomes of distal humerus fracture treatment using Patient-Reported Outcomes Measurement Information System (PROMIS) or QuickDASH (Disabilities of the Arm, Shoulder, and Hand) scores and the association between patient-reported outcomes and clinical outcomes. Methods: We performed a retrospective cohort study of 76 adult patients who sustained an acute distal humerus fracture between 2016 and 2018; 53 patients completed at least one patient-reported outcome measure used to assess physical function (PF) during their routine follow-up care (69.7% response rate). The average time to follow-up patient-reported outcome measure was 10.3 months. Patients completed the PROMIS PF 10a, PROMIS upper extremity (UE) 16a, and/or QuickDASH based on the treating institution/service. In addition, the PROMIS Global (Mental) subscale score was used as a measure of self-rated mental health. To assess clinical outcomes, we measured radiographic union, range of motion, and postoperative complications. Results: Most fractures were intra-articular (67.9%), and 84.9% were treated surgically. After treatment, 98.1% of fractures united radiographically. By the final follow-up, the average arc of motion was 18° to 122°. Average (±SD) PROMIS PF and UE scores were 41.7 ± 11.1 and 40.8 ± 12.4, respectively. The average QuickDASH score was 39.4 ± 26.5. The arc of flexion-extension and PROMIS Global (Mental) score were independently associated with PROMIS PF and PROMIS UE scores. Conclusions: We found that clinical factors (the arc of flexion-extension) and patient psychological factors (PROMIS Global [Mental] score) were independently associated with PROMIS measures of PF after distal humerus fracture treatment. These data can be used to contextualize patient outcomes and guide patient expectations.

Conservative vs. operative treatment for humeral shaft fractures: a meta-analysis and systematic review of randomized clinical trials and observational studies.

BACKGROUND: This meta-analysis aimed to compare conservative vs. operative treatment for humeral shaft fractures in terms of the nonunion rate, reintervention rate, permanent radial nerve palsy rate, and functional outcomes. Secondarily, effect estimates from observational studies were compared with estimates of randomized clinical trials (RCTs). METHODS: The PubMed/Medline, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases were searched for both RCTs and observational studies comparing conservative with operative treatment for humeral shaft fractures. RESULTS: A total of 2 RCTs (150 patients) and 10 observational studies (1262 patients) were included. The pooled nonunion rate of all studies was higher in patients treated conservatively (15.3%) vs. operatively (6.4%) (risk difference, 8%; odds ratio [OR], 2.9; 95% confidence interval [CI], 1.8-4.5; I2 = 0%). The reintervention rate was also higher for conservative treatment (14.3%) than for operative treatment (8.9%) (risk difference, 6%; OR, 1.9; 95% CI, 1.1-3.5; I2 = 30%). The higher reintervention rate was predominantly attributable to the higher nonunion rate in patients treated conservatively. The permanent radial nerve palsy rate was equal in both groups (OR, 0.6; 95% CI, 0.2-1.9; I2 = 18%). There appeared to be no difference in mean time to union and mean Disabilities of the Arm, Shoulder and Hand scores between the treatment groups. No difference was found between effect estimates form observational studies and RCTs. CONCLUSION: This systematic review shows that satisfactory results can be achieved with both conservative and operative management; however, operative treatment reduces the risk of nonunion compared with conservative treatment, with comparable reintervention rates (for indications other than nonunion). Furthermore, operative treatment results in a similar permanent radial nerve palsy rate, despite its inherent additional surgery-related risks. No difference in mean time-to-union and short-term functional results was detected.

Operative vs Nonoperative Treatment of Distal Radius Fractures in Adults: A Systematic Review and Meta-analysis.

Importance: No consensus has been reached to date regarding the optimal treatment for distal radius fractures. The international rate of operative treatment has been increasing, despite higher costs and limited functional outcome evidence to support this shift. Objectives: To compare functional, clinical, and radiologic outcomes after operative vs nonoperative treatment of distal radius fractures in adults. Data Sources: The PubMed/MEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases were searched from inception to June 15, 2019, for studies comparing operative vs nonoperative treatment of distal radius fractures. Study Selection: Randomized clinical trials (RCTs) and observational studies reporting on the following: acute distal radius fracture with operative treatment (internal or external fixation) vs nonoperative treatment (cast immobilization, splinting, or bracing); patients 18 years or older; and functional outcome. Studies in a language other than English or reporting treatment for refracture were excluded. Data Extraction and Synthesis: Data extraction was performed independently by 2 reviewers. Effect estimates were pooled using random-effects models and presented as risk ratios (RRs) or mean differences (MDs) with 95% CIs. Data were analyzed in September 2019. Main Outcomes and Measures: The primary outcome measures included medium-term functional outcome measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) and the overall complication rate after operative and nonoperative treatment. Results: A total of 23 unique studies were included, consisting of 8 RCTs and 15 observational studies, that described 2254 unique patients. Among the studies that presented sex data, 1769 patients were women [80.6%]. Overall weighted mean age was 67 [range, 22-90] years). The RCTs included 656 patients (29.1%); observational studies, 1598 patients (70.9%). The overall pooled effect estimates the showed a significant improvement in medium-term (≤1 year) DASH score after operative treatment compared with nonoperative treatment (MD, -5.22 [95% CI, -8.87 to -1.57]; P = .005; I2 = 84%). No difference in complication rate was observed (RR, 1.03 [95% CI, 0.69-1.55]; P = .87; I2 = 62%). A significant improvement in grip strength was noted after operative treatment, measured in kilograms (MD, 2.73 [95% CI, 0.15-5.32]; P = .04; I2 = 79%) and as a percentage of the unaffected side (MD, 8.21 [95% CI, 2.26-14.15]; P = .007; I2 = 76%). No improvement in medium-term DASH score was found in the subgroup of studies that only included patients 60 years or older (MD, -0.98 [95% CI, -3.52 to 1.57]; P = .45; I2 = 34%]), compared with a larger improvement in medium-term DASH score after operative treatment in the other studies that included patients 18 years or older (MD, -7.50 [95% CI, -12.40 to -2.60]; P = .003; I2 = 77%); the difference between these subgroups was statically significant (test for subgroup differences, P = .02). Conclusions and Relevance: This meta-analysis suggests that operative treatment of distal radius fractures improves the medium-term DASH score and grip strength compared with nonoperative treatment in adults, with no difference in overall complication rate. The findings suggest that operative treatment might be more effective and have a greater effect on the health and well-being of younger, nonelderly patients.

Long-term outcomes after open reduction and internal fixation of bicondylar tibial plateau fractures.

INTRODUCTION: To establish normative data, long-term patient-reported functional outcome and health-related quality of life (HrQoL) after operative treatment of bicondylar tibial plateau fractures. Secondly, to identify risk factors associated with functional outcome and HrQoL. PATIENTS AND METHODS: We performed a retrospective cohort study at two Level I trauma centers. All adult patients with AO/OTA 41-C or Schatzker V/ VI tibial plateau fractures treated between 2001 and 2016 (n = 450) by open reduction internal fixation (ORIF). The survey was completed by 214 patients (48%). Primary outcome was patient-reported functional outcome assessed with the PROMIS Physical Function (PROMIS PF). Secondary outcomes were HrQoL measured with the EuroQol 5-Dimensions 3-Levels (EQ-5D-3 L), infection rate, and total knee arthroplasty (TKA) rate. RESULTS: Infection occurred in 26 cases (12%) and TKA was performed in 6 patients (3%). The median PROMIS PF scores was 49.8 (IQR;42-54). The median EQ-5D-3 L was 0.83 (IQR;0.78-1.0).%). The multivariable regression model revealed female gender, diabetes, and worse HrQoL were correlated with worse functional outcome. The multivariable regression model revealed smoking, diabetes, and the subsequent need for TKA to be correlated with worse HrQoL. CONCLUSION: The PROMIS PF and EQ-5D-3L did not reach a minimum clinically important difference. The PROMIS PF items revealed patients had no difficulty in walking more than a mile or climbing a flight of stairs. However, patients were limited in doing vigorous activities and patients should be counseled about the expected long-term outcomes. This study emphasizes the correlation between injury specific functional outcome measures and general health measures. LEVEL OF EVIDENCE: Therapeutic Level III.

Injury-related variation in patient-reported outcome after musculoskeletal trauma: a systematic review.

PURPOSE: The purpose of this study was to explore injury-related characteristics that differentiate between patient-reported outcomes (PROs) following traumatic musculoskeletal injury. METHODS: We reviewed English-language articles in PubMed/MEDLINE, Google Scholar, and the Cochrane Database of Systematic Reviews (January 1995 to September 2018). We included studies that compared patient-reported outcomes of musculoskeletal trauma based on injury characteristics, and excluded studies related to development or validation of outcome tools without implementation, measurement, or comparison. Studies on patients with isolated neurotrauma or spine trauma were not included. Study level of evidence was assessed by 2 reviewers using the modified Oxford Centre for Evidence-based Medicine rating system. RESULTS: A total of 20 studies (21 articles) that reported on a total of 10,186 patients were included (4 were prospective cohort-studies, 8 were matched-control retrospective cohort-studies, and 8 were retrospective cohort-studies). Median minimum follow-up was 3 years (range 0.5-10 years). Injury-related factors associated with worse PROs were polytrauma or multiple injuries (10 studies), neurotrauma (11 studies), and high-energy injury mechanism (7 studies). Among all studies, 32 different outcome metrics were used (17 general health status metrics and 15 limb-specific metrics) making meta-analysis infeasible. CONCLUSIONS: Based on the included studies, we propose a framework where musculoskeletal injuries occur in one of 4 scenarios that is associated with a different context-dependent outcome: (1) polytrauma with neurotrauma, (2) polytrauma without neurotrauma, (3) high-energy monotrauma, and (4) low-energy monotrauma. Our results suggest that standardization of outcome instruments is needed to facilitate future meta-analyses that assess PROs in this population.

Surgical treatment of acute and chronic AC joint dislocations: Five-year experience with conventional and modified LARS fixation by a single surgeon.

BACKGROUND: Different surgical fixation methods are available for the treatment of acromioclavicular (AC) joint dislocations. The aim of this study was to present the results of five years of experience with the Ligament Augmentation and Reconstruction System (LARS) fixation technique by a single surgeon. METHODS: A single-center retrospective cohort study was performed. All patients treated for an AC joint dislocation with LARS fixation by the same surgeon between 2012 and 2016 (n = 20) were eligible for inclusion. All these dislocations were unstable injuries, Rockwood type-III or higher, requiring acute or chronic repair. The primary outcome was the QuickDASH score. Secondary outcomes were the Subjective Shoulder Value (SSV), Numerical Rating Scale (NRS) pain score, return to work, complications, and implant removal. RESULTS: 17 patients (85%) were available for final follow-up. The median follow-up was 23 months (IQR; 17─34). The median QuickDASH score was 7 (IQR; 2-18), the median SSV was 90 (IQR; 80-90), and the median NRS pain score was 2 (IQR; 1-3). Patients returned to work after a median of 8 weeks (IQR; 6-12). There was no significant difference in functional outcome scores between acute and chronic repair, or between the conventional and modified LARS fixation groups. There were two major complications requiring revision surgery, one ruptured LARS ligament and one case of deep wound infection. Implant removal was performed in one patient. CONCLUSIONS: The LARS ligament fixation technique seems to be effective for the treatment of AC joint dislocations, resulting in good short- and mid-term patient-reported functional outcome. LARS fixation might also be an acceptable treatment option for active patients with symptomatic chronic AC dislocations. LEVEL OF EVIDENCE: Level III, Retrospective Comparative Study, Treatment Study.

Nonunion of the Capitate due to Delayed Diagnosis of an Isolated Fracture: A Case Report.

CASE: A 14-year-old girl was diagnosed with nonunion of an isolated capitate fracture 5 months after she first presented to the emergency department. The fracture of the capitate was treated by cancellous proximal bone graft and screw fixation. This current case provides details of the surgical fixation method and long-term functional outcome after nonunion of an isolated capitate fracture after a follow-up of 18 months following fixation. CONCLUSIONS: Persisting localized tenderness over the capitate should be an indication to perform an additional computed tomography or magnetic resonance imaging scan. Nonunion of isolated capitate fractures can be treated by means of open reduction and internal fixation, with autologous bone grafting.

Surgical treatment of Neer type II and type V lateral clavicular fractures: comparison of hook plate versus superior plate with lateral extension: a retrospective cohort study.

PURPOSE: Different fixation methods are used for treatment of unstable lateral clavicle fractures (LCF). Definitive consensus and guidelines for the surgical fixation of LCF have not been established. The aim of this study was to compare patient-reported functional outcome after open reduction and internal fixation with the clavicle hook plate (CHP) and the superior clavicle plate with lateral extension (SCPLE). METHODS: A dual-center retrospective cohort study was performed. All patients operatively treated for unstable Neer type II and type V LCF between 2011 and 2016, with the CHP (n = 23) or SCPLE (n = 53), were eligible for inclusion. The primary outcome was the QuickDASH score. Secondary outcomes were the numerical rating scale (NRS) pain score, complications, and implant removal. RESULTS: A total of 67 patients (88%) were available for the final follow-up. There was a significant difference in bicortical lateral fragment size, 15 mm (± 4, range 6-21) in the CPH group compared to 20 mm (± 8, range 8-43) in the SCPLE group (p ≤ 0.001). There was no significant difference in median QuickDASH score (CHP; 0.00 [IQR 0.0-0.0], SCPLE; 0.00 [IQR 0.0-4.5]; p = 0.073) or other functional outcome scores (NRS at rest; p = 0.373, NRS during activity; p = 0.559). There was no significant difference in median QuickDASH score or other functional outcome scores between Neer type II and type V fractures. There was no significant difference in complication rate, CHP 11% and SCPLE 8% (relative risk 1.26; [95% CI 0.25-6.33; p = 0.777]). The implant removal rate was 100% in the CHP group compared to 42% in the SCPLE group (relative risk 2.40; [95% CI 1.72-3.35; p ≤ 0.001]). CONCLUSION: Both the CHP and SCPLE are effective fixation methods for the treatment of unstable LCF, resulting in excellent patient-reported functional outcome and similar complication rates. SCPLE fixation is an effective fixation method for the treatment of both Neer type II and type V LCF. The SCPLE has a lower implant removal rate. Therefore, if technically feasible, we recommend SCPLE fixation for the treatment of unstable LCF.

Operative treatment versus nonoperative treatment of Achilles tendon ruptures: systematic review and meta-analysis.

OBJECTIVES: To compare re-rupture rate, complication rate, and functional outcome after operative versus nonoperative treatment of Achilles tendon ruptures; to compare re-rupture rate after early and late full weight bearing; to evaluate re-rupture rate after functional rehabilitation with early range of motion; and to compare effect estimates from randomised controlled trials and observational studies. DESIGN: Systematic review and meta-analysis. DATA SOURCES: PubMed/Medline, Embase, CENTRAL, and CINAHL databases were last searched on 25 April 2018 for studies comparing operative versus nonoperative treatment of Achilles tendon ruptures. STUDY SELECTION CRITERIA: Randomised controlled trials and observational studies reporting on comparison of operative versus nonoperative treatment of acute Achilles tendon ruptures. DATA EXTRACTION: Data extraction was performed independently in pairs, by four reviewers, with the use of a predefined data extraction file. Outcomes were pooled using random effects models and presented as risk difference, risk ratio, or mean difference, with 95% confidence interval. RESULTS: 29 studies were included-10 randomised controlled trials and 19 observational studies. The 10 trials included 944 (6%) patients, and the 19 observational studies included 14 918 (94%) patients. A significant reduction in re-ruptures was seen after operative treatment (2.3%) compared with nonoperative treatment (3.9%) (risk difference 1.6%; risk ratio 0.43, 95% confidence interval 0.31 to 0.60; P<0.001; I2=22%). Operative treatment resulted in a significantly higher complication rate than nonoperative treatment (4.9% v 1.6%; risk difference 3.3%; risk ratio 2.76, 1.84 to 4.13; P<0.001; I2=45%). The main difference in complication rate was attributable to the incidence of infection (2.8%) in the operative group. A similar reduction in re-rupture rate in favour of operative treatment was seen after both early and late full weight bearing. No significant difference in re-rupture rate was seen between operative and nonoperative treatment in studies that used accelerated functional rehabilitation with early range of motion (risk ratio 0.60, 0.26 to 1.37; P=0.23; I2=0%). No difference in effect estimates was seen between randomised controlled trials and observational studies. CONCLUSIONS: This meta-analysis shows that operative treatment of Achilles tendon ruptures reduces the risk of re-rupture compared with nonoperative treatment. However, re-rupture rates are low and differences between treatment groups are small (risk difference 1.6%). Operative treatment results in a higher risk of other complications (risk difference 3.3%). The final decision on the management of acute Achilles tendon ruptures should be based on patient specific factors and shared decision making. This review emphasises the potential benefits of adding high quality observational studies in meta-analyses for the evaluation of objective outcome measures after surgical treatment.

Long-term outcomes after operative treatment for tibial pilon fractures.

OBJECTIVES: Aims of the present study were to establish generalizable outcome data on long-term functional outcomes and health-related quality of life (HRQoL) after operative treatment of pilon fractures on a large scale. Second, it was aimed to examine factors associated with these outcomes. DESIGN: Retrospective cohort study with follow-up by questionnaire. SETTING: Two level 1 trauma centers. PATIENTS: Two hundred twenty-five of 480 eligible patients completed the survey (response rate 47%). INTERVENTION: Open reduction internal fixation for tibial pilon fracture. MAIN OUTCOME MEASUREMENTS: Ankle function measured using the Foot and Ankle Ability Measure, physical function using the Patient-Reported Outcomes Measurement System Physical Function (PROMIS PF, Short Form 10a) questionnaire and HRQoL using the EuroQol 5-Dimensions 3-Level (EQ-5D-3L) questionnaire. RESULTS: At a medium follow-up of 82 months (82 (interquartile range (IQR), 45-120), median Foot and Ankle Ability Measure was 74 (IQR, 57-82), median PROMIS PF 49 (IQR, 44-57), median EQ-5D-3L 0.81 (IQR, 0.71-0.84). HRQoL was significantly lower compared to a reference population (P < .001). In multivariable regression analyses, smoking was associated with poorer HRQoL. Higher body mass index, deep infection, and lower HRQoL were associated with worse ankle function. CONCLUSIONS: Long-term patient-reported outcomes after operative treatment of pilon fractures reveal impaired functionality and lower HRQoL compared to an uninjured reference population. As pilon fractures can have significant effects on a patient's life, patients should be counseled about the expected long-term outcomes to set realistic expectations. This study emphasizes the importance of obtaining both general and region-specific measures when evaluating outcomes after injury, in order to evaluate the injury of interest in the accurate context. LEVEL OF EVIDENCE: Prognostic level III.

Operative versus nonoperative treatment of proximal humeral fractures: a systematic review, meta-analysis, and comparison of observational studies and randomized controlled trials.

BACKGROUND: There is no consensus on the choice of treatment for displaced proximal humeral fractures in older patients (aged > 65 years). The aims of this systematic review and meta-analysis were (1) to compare operative with nonoperative management of displaced proximal humeral fractures and (2) to compare effect estimates obtained from randomized controlled trials (RCTs) and observational studies. METHODS: The databases of MEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) were searched on September 5, 2017, for studies comparing operative versus nonoperative treatment of proximal humeral fractures; both RCTs and observational studies were included. The criteria of the Methodological Index for Non-Randomized Studies, a validated instrument for methodologic quality assessment, were used to assess study quality. The primary outcome measure was physical function as measured by the absolute Constant-Murley score after operative or nonoperative treatment. Secondary outcome measures were major reinterventions, nonunion, and avascular necrosis. RESULTS: We included 22 studies, comprising 7 RCTs and 15 observational studies, resulting in 1743 patients in total: 910 treated operatively and 833 nonoperatively. The average age was 68.3 years, and 75% of patients were women. There was no difference in functional outcome between operative and nonoperative treatment, with a mean difference of -0.87 (95% confidence interval, -5.13 to 3.38; P = .69; I2 = 69%). Major reinterventions occurred more often in the operative group. Pooled effects of RCTs were similar to pooled effects of observational studies for all outcome measures. CONCLUSIONS: We recommend nonoperative treatment for the average elderly patient (aged > 65 years) with a displaced proximal humeral fracture. Pooled effects of observational studies were similar to those of RCTs, and including observational studies led to more generalizable conclusions.