Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management: The INSITE Randomized Clinical Trial.

Importance: Fractures of the hip have devastating effects on function and quality of life. Intramedullary nails (IMN) are the dominant implant choice for the treatment of trochanteric fractures of the hip. Higher costs of IMNs and inconclusive benefit in comparison with sliding hip screws (SHSs) convey the need for definitive evidence. Objective: To compare 1-year outcomes of patients with trochanteric fractures treated with the IMN vs an SHS. Design, Setting, and Participants: This randomized clinical trial was conducted at 25 international sites across 12 countries. Participants included ambulatory patients aged 18 years and older with low-energy trochanteric (AO Foundation and Orthopaedic Trauma Association [AO/OTA] type 31-A1 or 31-A2) fractures. Patient recruitment occurred between January 2012 and January 2016, and patients were followed up for 52 weeks (primary end point). Follow-up was completed in January 2017. The analysis was performed in July 2018 and confirmed in January 2022. Interventions: Surgical fixation with a Gamma3 IMN or an SHS. Main Outcomes and Measures: The primary outcome was health-related quality of life (HRQOL), measured by the EuroQol-5 Dimension (EQ5D) at 1-year postsurgery. Secondary outcomes included revision surgical procedure, fracture healing, adverse events, patient mobility (measured by the Parker mobility score), and hip function (measured by the Harris hip score). Results: In this randomized clinical trial, 850 patients were randomized (mean [range] age, 78.5 [18-102] years; 549 [64.6% female) with trochanteric fractures to undergo fixation with either the IMN (n = 423) or an SHS (n = 427). A total of 621 patients completed follow-up at 1 year postsurgery (304 treated with the IMN [71.9%], 317 treated with an SHS [74.2%]). There were no significant differences between groups in EQ5D scores (mean difference, 0.02 points; 95% CI, -0.03 to 0.07 points; P = .42). Furthermore, after adjusting for relevant covariables, there were no between-group differences in EQ5D scores (regression coefficient, 0.00; 95% CI, -0.04 to 0.05; P = .81). There were no between-group differences for any secondary outcomes. There were also no significant interactions for fracture stability (ß [SE] , 0.01 [0.05]; P = .82) or previous fracture (ß [SE], 0.01 [0.10]; P = .88) and treatment group. Conclusions and Relevance: This randomized clinical trial found that IMNs for the treatment of trochanteric fractures had similar 1-year outcomes compared with SHSs. These results suggest that the SHS is an acceptable lower-cost alternative for trochanteric fractures of the hip. Trial Registration: ClinicalTrials.gov Identifier: NCT01380444.

Trends in Outpatient Total Knee Arthroplasty From 2012 to 2020.

BACKGROUND: Trends over the past decade suggest a steady increase in the proportion of total knee arthroplasty (TKA) performed on an outpatient basis. However, the optimal patient selection criteria for outpatient TKA remain unclear. We aimed to describe longitudinal trends in patients selected for outpatient TKA and identify risk factors for 30-day morbidity following inpatient and outpatient TKA. METHODS: We identified 379,959 primary TKA patients, 17,170 (4.5%) of whom underwent outpatient surgery from 2012 to 2020 within a large national database. We used regression models to evaluate trends in outpatient TKA, factors associated with undergoing outpatient (versus inpatient) TKA and 30-day morbidity following outpatient and inpatient TKA. We used receiver operating curves to examine cutoff points for continuous risk factors. RESULTS: The proportion of patients undergoing outpatient TKA increased from 0.4% in 2012 to 14.1% in 2020. Younger age, male sex, lower body mass index (BMI), higher hematocrit, and fewer comorbidities were associated with receiving outpatient (versus inpatient) TKA. Variables associated with 30-day morbidity in the outpatient group included older age, chronic dyspnea, chronic obstructive pulmonary disease, and higher BMI. The receiver operating curves indicated outpatients aged 68 years and older, or with a BMI of 31.4 or higher were more likely to experience 30-day complications. CONCLUSION: The proportion of patients undergoing outpatient TKA has been increasing since 2012. Older age (≥68 years), a higher BMI (≥31.4), and comorbidities such as chronic dyspnea, chronic obstructive pulmonary disease, diabetes, and hypertension were associated with an increased odd of 30-day morbidity following outpatient TKA.

Decreasing Trend in Complications for Patients With Obesity and Metabolic Syndrome Undergoing Total Knee Arthroplasty From 2006 to 2017.

BACKGROUND: To describe longitudinal trends in patients with obesity and Metabolic Syndrome (MetS) undergoing total knee arthroplasty (TKA) and the impact on complications. METHODS: We identified primary TKA patients between 2006 and 2017 within the National Surgical Quality Improvement Program database. We recorded patient demographics and 30-day complications. We labeled those with an obese Body Mass Index (BMI ≥30), hypertension, and diabetes as having MetS. We used regression to evaluate trends in BMI and complications over time and variables associated with the odds of complication. RESULTS: We identified 270,846 TKA patients, 63.71% of which were obese (n = 172,333), 15.21% morbidly obese (n = 41,130), and 12.37% met the criteria for MetS (n = 33,470). Mean BMI increased by 0.03 per year (0.02-0.05). Despite this, the odds of adverse events in obese patients decreased: major complications by 0.94 (0.93-0.96) and minor complications by 0.94 (0.93-0.95). The proportion of patients with MetS remained stable; however, we found improvements in major (0.94 [0.91-0.97]) and minor complications (0.97 [0.94-1.00]) over time. MetS components (hypertension, diabetes, and BMI ≥40) were associated with major and minor complications in obese patients, while neuraxial anesthesia lowered the odds of major complications in obese patients (0.87 [0.81-0.92]). CONCLUSION: Mean BMI in primary TKA patients increased from 2006 to 2017. MetS components diabetes and hypertension elevated the odds of complications in obese patients. Rates of complications in patients with obesity and MetS exhibited a longitudinal decline. These findings may reflect increased awareness and improved management of these patients.

Development and Internal Validation of Novel Risk Tools to Predict Subsequent Shoulder Surgery After Proximal Humerus Fractures.

OBJECTIVE: To (1) identify predictors of subsequent surgery after initial treatment of proximal humerus fractures (PHFs) and (2) generate valid risk prediction tools to predict subsequent surgery. METHODS: We identified patients ≥50 years with PHF from 2004 to 2015 using health data sets in Ontario, Canada. We used procedural codes to classify patients into treatment groups of (1) surgical fixation, (2) shoulder replacement, and (3) conservative. We used procedural and diagnosis codes to capture subsequent surgery within 2 years after fracture. We developed regression models for two-thirds of each group to identify predictors of subsequent surgery and the regression equations to develop risk tools to predict subsequent surgery. We used the final third of each cohort to evaluate the discriminative ability of the risk tools using c-statistics. RESULTS: We identified 20,897 patients with PHF, 2414 treated with fixation, 1065 with replacement, and 17,418 treated conservatively. Predictors of reoperation after fixation included bone grafting and nail or wire fixation versus plate fixation, whereas poor bone quality was associated with reoperation after initial replacement. In conservatively treated patients, more comorbidities were associated with subsequent surgery, whereas age 70+ and discharge home after presentation lowered the odds of subsequent surgery. The risk tools were able to discriminate with c-statistics of 0.75-0.88 (derivation) and 0.51-0.79 (validation). CONCLUSIONS: Our risk tools showed good to strong discriminative ability for patients treated conservatively and with fixation. These data may be used as the foundation to develop a clinically informative tool. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

A Comparison of Acute Complications and Mortality Between Geriatric Knee and Hip Fractures: A Matched Cohort Study.

INTRODUCTION: To compare acute complication and mortality rates for operatively treated, closed, isolated, low-energy geriatric knee fractures (distal femur [DFF] or tibial plateau [TPF]) with hip fractures (HFs). METHODS: This is a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program. We identified all patients ≥ 70 years from 2011 to 2016 who underwent surgery for DFF, TPF, or HF. We recorded patient demographics, functional status, complications, and mortality. We matched DFF:TPF:HF patients on a 1:1:10 ratio based on age, sex, body mass index, baseline functional status, and comorbidity. We used the chi square, Fisher exact, and Mann Whitney U tests to compare unadjusted differences between groups and multivariable logistic regression to compare the risk of complications, readmission, or death while adjusting for relevant covariates. RESULTS: When compared with HF, patients in the DFF and TPF groups had longer length of stay and time to index surgery and were more likely to be discharged home. The rate of deep vein thrombosis was significantly higher in the TPF group (TPF = 3.9%, DFF = 1.3%, and HF = 1.2%, P = 0.005). CONCLUSION: Geriatric knee fractures pose a similar risk of acute complications, mortality, and readmission compared with patients with HF. Future studies investigating strategies to decrease risk in this patient cohort are warranted. LEVEL OF EVIDENCE: Therapeutic Level III.

Operative Versus Nonoperative Treatment of Acute Displaced Distal Clavicle Fractures: A Multicenter Randomized Controlled Trial.

OBJECTIVES: To evaluate the differences in patient outcomes after operative or nonoperative treatment of displaced, type II distal clavicle fractures. DESIGN: Multicenter, prospective, randomized controlled trial. SETTING: Level I trauma centers. PATIENTS/PARTICIPANTS: Patients with completely displaced type II distal clavicle fractures were included. Fifty-seven patients were randomized: 27 to the operative group and 30 to the nonoperative group. INTERVENTION: Patients randomized to nonoperative care received a standard shoulder sling, followed by pendulum or gentle range of motion shoulder exercises at any time as directed by the attending surgeon. Patients randomized to the operative group received plate fixation with a precontoured distal clavicular plate or a "hook" plate within 28 days from injury. MAIN OUTCOME MEASURE: Disabilities of the Arm, Shoulder and Hand scores at 1 year. RESULTS: There were no between-group differences in Disabilities of the Arm, Shoulder and Hand or Constant scores at 1 year. More patients in the operative group went on to union (95% vs. 64%, P = 0.02) within 1 year. Twelve patients in the operative group underwent a second operation for implant removal (12/27, 44%). In the nonoperative group, 6 patients (6/30, 20%) subsequently underwent 8 operative procedures. CONCLUSION: Although this study failed to demonstrate a difference in functional outcomes between operative and nonoperative treatment of Neer type II distal clavicle fractures, nonoperative management led to more complications including a moderate rate of nonunion, which often required secondary surgery to correct, a higher rate of early dissatisfaction with shoulder appearance, and a delayed return to activities in the first 6 months. Operative management provided a safe and reliable treatment option with few complications, but often required secondary implant removal, especially with hook plate fixation. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

A concept analysis and overview of outcome measures used for evaluating patients with proximal humerus fractures.

PURPOSE: It is unclear to which degree existing studies evaluate the primary goal of treatment for patients with proximal humerus fractures (restoration of daily activities). Our purpose was to systematically review and analyze the concepts reflected by outcome measures used in studies of patients with proximal humerus fractures. METHODS: We reviewed three databases from 2000 to 2018. Two reviewers categorized outcomes in each study into concepts of the International Classification of Functioning, Disability and Health framework. RESULTS: The most commonly represented concept across 35 studies was "Body Function/Structure Impairment", followed by aggregate measures that reflect multiple concepts to varying degrees. All patient-reported aggregate measures such as the Disabilities of the Arm, Shoulder, and Hand, American Shoulder and Elbow Surgeon's, and Oxford Shoulder scores better reflected "Activity Limitations", however, these measures were only reported in 34% of studies. CONCLUSION: There may be misalignment between what studies measure, and the primary goal of treatment for patients with proximal humerus fractures. The Disabilities of the Arm, Shoulder and Hand, American Shoulder and Elbow Surgeon's, and Oxford Shoulder scores reflect concepts that more adequately address the restoration of daily activities following these injuries, and future studies should include at least one of these measures.Implications for rehabilitationWe have shown that there is a misalignment between what existing studies are measuring (primarily objective measures of impairment) and the primary goal of treatment and rehabilitation (restoring activities of daily living).This suggests that existing studies evaluating different treatment types for proximal humerus fracture patients are providing inadequate information to make evidence-based treatment and rehabilitation decisions following theses injuries.Our results tentatively suggest that the Disabilities of the Arm, Shoulder and Hand, the American Shoulder and Elbow Surgeon's, and Oxford Shoulder scores may better reflect limitations in daily activities following these injuries and should be used in future studies and by clinicians.

A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures.

BACKGROUND: Romosozumab is a bone-forming antibody that increases bone formation and decreases bone resorption. We conducted a double-blinded, randomized, phase-2, dose-finding trial to evaluate the effect of romosozumab on the clinical outcomes of open reduction and internal fixation of intertrochanteric or femoral neck hip fractures. METHODS: Patients (55 to 94 years old) were randomized 2:3:3:3 to receive 3 subcutaneous injections of romosozumab (70, 140, or 210 mg) or a placebo postoperatively on day 1 and weeks 2, 6, and 12. The primary end point was the difference in the mean timed "Up & Go" (TUG) score over weeks 6 to 20 for romosozumab versus placebo. Additional end points included the time to radiographic evidence of healing and the score on the Radiographic Union Scale for Hip (RUSH). RESULTS: A total of 332 patients were randomized: 243 to receive romosozumab (70 mg, n = 60; 140 mg, n = 93; and 210 mg, n = 90) and 89 to receive a placebo. Although TUG scores improved during the study, they did not differ significantly between the romosozumab and placebo groups over weeks 6 to 20 (p = 0.198). The median time to radiographic evidence of healing was 16.4 to 16.9 weeks across treatment groups. The RUSH scores improved over time across treatment groups but did not differ significantly between the romosozumab and placebo groups. The overall safety and tolerability profile of romosozumab was comparable with that of the placebo. CONCLUSIONS: Romosozumab did not improve the fracture-healing-related clinical and radiographic outcomes in the study population. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

A higher reoperation rate following arthroplasty for failed fixation versus primary arthroplasty for the treatment of proximal humeral fractures: a retrospective population-based study.

AIMS: To compare complication-related reoperation rates following primary arthroplasty for proximal humerus fractures (PHFs) versus secondary arthroplasty for failed open reduction and internal fixation (ORIF). PATIENTS AND METHODS: We identified patients aged 50 years and over, who sustained a PHF between 2004 and 2015, from linkable datasets. We used intervention codes to identify patients treated with initial ORIF or arthroplasty, and those treated with ORIF who returned for revision arthroplasty within two years. We used multilevel logistic regression to compare reoperations between groups. RESULTS: We identified 1624 patients who underwent initial arthroplasty for PHF, and 98 patients who underwent secondary arthroplasty following failed ORIF. In total, 72 patients (4.4%) in the primary arthroplasty group had a reoperation within two years following arthroplasty, compared with 19 patients (19.4%) in the revision arthroplasty group. This difference was significantly different (p < 0.001) after covariable adjustment. CONCLUSION: The number of reoperations following arthroplasty for failed ORIF of PHF is significantly higher compared with primary arthroplasty. This suggests that primary arthroplasty may be a better choice for patients whose prognostic factors suggest a high reoperation rate following ORIF. Prospective clinical studies are required to confirm these findings. Cite this article: Bone Joint J 2019;101-B:1272-1279.

A Systematic Review and Standardized Comparison of Available Evidence for Outcome Measures Used to Evaluate Proximal Humerus Fracture Patients.

OBJECTIVES: To summarize and appraise any patient-reported or clinician-measured outcome measures based on their measurement properties in proximal humerus fracture patients. DATA SOURCES AND STUDY SELECTION: MEDLINE, EMBASE, and CINAHL were searched from January 2000 to August 2018 to identify all studies of proximal humerus fracture patients that reported a measurement property evaluation of an outcome measure. DATA EXTRACTION AND SYNTHESIS: Quality appraisal of each measure was completed using the Evaluating the Measurement of Patient-Reported Outcomes (EMPRO) tool. The EMPRO takes into account all studies of each measure, and the overall score is transformed linearly to a range of 0 (lowest) to 100 (best). RESULTS: Eleven instruments were identified. Intended concepts of the instruments included clinician-measured shoulder function, patient-reported function or disability, and patient-reported general health state. Only the Disabilities of the Arm, Shoulder and Hand (DASH), Oxford Shoulder Score, Constant Score, University of California, Los Angeles Shoulder Score, and EuroQol 5 Dimension (EQ5D) were evaluated in more than 1 study. The Shoulder Function Index (SFINX), DASH, and EQ5D had the highest EMPRO scores (80, 66, and 58, respectively). The SFINX and DASH consistently scored among the top 3 instruments for each attribute. CONCLUSIONS: Evidence on the measurement properties of outcome measures for proximal humerus fracture patients is limited. With the available evidence, the SFINX is recommended as a clinician-measured functional outcome measure, the DASH as a patient-reported functional outcome measure, and the EQ5D as a general health status measure.

Plate fixation for management of humerus fractures.

Proximal humerus, humeral shaft, and distal humerus fractures are all common adult fractures, and often occur in older patients. While the treatment of proximal humerus fractures remains controversial, certain fractures benefit from plate fixation such as fracture-dislocations and head-split fractures. When plate fixation is chosen, anatomic reduction and restoration of the medial calcar are important for successful results. Further research is required to minimize complications and determine the optimal surgical candidates for plate fixation. Humeral shaft fractures are generally treated non-operatively. However, certain shaft fractures warrant plate fixation, such as open fractures, those with associated forearm fractures, and those in poly-trauma patients. Choice of surgical approach and plate depends on the location and type of the fracture. The majority of intra-articular distal humerus fractures should be treated with plate fixation. Dual plating is generally accepted as the gold standard treatment, while the optimal surgical approach and plate configuration requires more research.

Orthopaedic surgeons' opinions surrounding the management of proximal humerus fractures: an international survey.

PURPOSE: The purpose of this study was to survey surgeons' preferences surrounding the management and evaluation of proximal humerus fractures internationally. METHODS: A questionnaire was developed using previous literature and input from practicing orthopaedic surgeon opinion leaders. Between November 13, 2014 and December 31, 2014, the questionnaire was posted on the membership section of three major orthopaedic and shoulder surgery association websites. Survey responses were anonymous. RESULTS: The survey was completed by 134 unique practicing orthopaedic surgeons. The majority of respondents (72%) practiced in North America while 28% practiced internationally. For displaced two-part fractures, a preference for open reduction and internal fixation (ORIF) with locking plates was identified (75%). No consensus was reached for preferred treatment of three- and four- part fractures: 37% chose ORIF with locking plates, 26% chose hemi-arthroplasty (HA), and 29% chose reverse shoulder arthroplasty (RSA). Preferred treatment types for three- and four-part fractures were marginally significantly different depending on place of practice (North America vs. international, p = 0.058). A significantly larger proportion of surgeons who had completed an upper extremity fellowship (35%) chose RSA for the treatment of three and four-part fractures, compared to those who had not (9%, p = 0.002). No consensus was observed regarding what outcome measure is best to assess function following proximal humerus fractures. CONCLUSIONS: The management of more complex, displaced proximal humerus fractures remains controversial. Additionally, there are conflicting opinions on what outcome measure is best to assess function following the treatment of proximal humerus fractures.