Posterolateral or Direct Lateral Surgical Approach for Hemiarthroplasty After a Hip Fracture: A Randomized Clinical Trial Alongside a Natural Experiment.

Importance: Hip fractures in older adults are serious injuries that result in disability, higher rates of illness and death, and a substantial strain on health care resources. High-quality evidence to improve hip fracture care regarding the surgical approach of hemiarthroplasty is lacking. Objective: To compare 6-month outcomes of the posterolateral approach (PLA) and direct lateral approach (DLA) for hemiarthroplasty in patients with acute femoral neck fracture. Design, Setting, and Participants: This multicenter, randomized clinical trial (RCT) comparing DLA and PLA was performed alongside a natural experiment (NE) at 14 centers in the Netherlands. Patients aged 18 years or older with an acute femoral neck fracture were included, with or without dementia. Secondary surgery of the hip, pathological fractures, or patients with multitrauma were excluded. Recruitment took place between February 2018 and January 2022. Treatment allocation was random or pseudorandom based on geographical location and surgeon preference. Statistical analysis was performed from July 2022 to September 2022. Exposure: Hemiarthroplasty using PLA or DLA. Main Outcome and Measures: The primary outcome was health-related quality of life 6 months after surgery, quantified with the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L). Secondary outcomes included dislocations, fear of falling and falls, activities of daily living, pain, and reoperations. To improve generalizability, a novel technique was used for data fusion of the RCT and NE. Results: A total of 843 patients (542 [64.3%] female; mean [SD] age, 82.2 [7.5] years) participated, with 555 patients in the RCT (283 patients in the DLA group; 272 patients in the PLA group) and 288 patients in the NE (172 patients in the DLA group; 116 patients in the PLA group). In the RCT, mean EQ-5D-5L utility scores at 6 months were 0.50 (95% CI, 0.45-0.55) after DLA and 0.49 (95% CI, 0.44-0.54) after PLA, with 77% completeness. The between-group difference (-0.04 [95% CI, -0.11 to 0.04]) was not statistically significant nor clinically meaningful. Most secondary outcomes were comparable between groups, but PLA was associated with more dislocations than DLA (RCT: 15 of 272 patients [5.5%] in PLA vs 1 of 283 patients [0.4%] in DLA; NE: 6 of 113 patients [5.3%]) in PLA vs 2 of 175 patients [1.1%] in DLA). Data fusion resulted in an effect size of 0.00 (95% CI, -0.04 to 0.05) for the EQ-5D-5L and an odds ratio of 12.31 (95% CI, 2.77 to 54.70) for experiencing a dislocation after PLA. Conclusions and Relevance: This combined RCT and NE found that among patients treated with a cemented hemiarthroplasty after an acute femoral neck fracture, PLA was not associated with a better quality of life than DLA. Rates of dislocation and reoperation were higher after PLA. Randomized and pseudorandomized data yielded similar outcomes, which suggests a strengthening of these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT04438226.

Posterolateral or direct lateral approach for cemented hemiarthroplasty after femoral neck fracture (APOLLO): protocol for a multicenter randomized controlled trial with economic evaluation and natural experiment alongside.

BACKGROUND AND PURPOSE: The posterolateral and direct lateral surgical approach are the 2 most common surgical approaches for performing a hemiarthroplasty in patients with a hip fracture. It is unknown which surgical approach is preferable in terms of (cost-)effectiveness and quality of life. METHODS AND ANALYSIS: We designed a multicenter randomized controlled trial (RCT) with an economic evaluation and a natural experiment (NE) alongside. We will include 555 patients ≥ 18 years with an acute femoral neck fracture. The primary outcome is patient-reported health-related quality of life assessed with the EQ-5D-5L. Secondary outcomes include healthcare costs, complications, mortality, and balance (including fear of falling, actual falls, and injuries due to falling). An economic evaluation will be performed for quality adjusted life years (QALYs). We will use variable block randomization stratified for hospital. For continuous outcomes, we will use linear mixed-model analysis. Dichotomous secondary outcome measures will be analyzed using chi-square statistics and logistic regression models. Primary analyses are based on the intention-to-treat principle. Additional as treated analyses will be performed to evaluate the effect of protocol deviations. Study summary: (i) Largest RCT addressing the health-related patient outcome of the main surgical approaches of hemiarthroplasty. (ii) Focus on outcomes that are important for the patient. (iii) Pragmatic and inclusive RCT with few exclusion criteria, e.g., patients with dementia can participate. (iv) Natural experiment alongside to amplify the generalizability. (v) The first study conducting a costutility analysis comparing both surgical approaches.

How are you doing in the eyes of your spouse? Level of agreement between the self-completed EQ-5D-5L and two proxy perspectives in an orthopaedic population: a randomized agreement study.

OBJECTIVES: To determine the level of agreement between both proxy versions and the self-completed EQ-5D-5L. DESIGN: A randomized agreement study. SETTING AND PARTICIPANTS: We recruited 120 patients (compos mentis) and their proxies at the orthopaedic outpatient clinic. Patients completed the regular EQ-5D-5L and their proxy completed the proxy version of the EQ-5D-5L and rated the patients' health from their own (proxy-proxy) perspective (i.e. how do you rate the health of the patient), and from the patient's (proxy-patient) perspective (i.e. how do you think the patient would rate their own health if they were able to). MEASURES: The primary outcome was the agreement between patients and their proxy, quantified as the intra class correlation coefficient for the EQ-5D-5L Utility score. RESULTS: Average Utility scores were 0.65 with the self completed EQ-5D-5L, versus 0.60 with the proxy-patient version and 0.58 with the proxy-proxy version. The ICC was 0.66 (95% CI 0.523, 0.753) for the proxy-patient perspective and 0.58 (95% CI 0.411, 0.697) for the proxy-proxy perspective. The mean gold standard score of the VAS-Health was 69.7 whereas the proxy-proxy perspective was 66.5 and the proxy-patient perspective was 66.3. CONCLUSION AND IMPLICATIONS: The proxy-patient perspective yielded substantial agreement with the self completed EQ-5D-5L, while the agreement with the proxy-proxy perspective was moderate. In this study population of patients without cognitive impairment, proxies tended to underestimate the quality of life of their relative.

Posterolateral or direct lateral approach for hemiarthroplasty after femoral neck fractures: a systematic review.

BACKGROUND: The posterolateral approach (PLA) and direct lateral approach (DLA) are the most commonly used approaches for inserting a hemiarthroplasty in the treatment of femoral neck fractures. A recent review concluded that the routine use of PLA should be questioned, but this conclusion itself can be questioned. The aim of this study is to provide an updated overview and critical appraisal of the available evidence, focussing on outcomes most relevant for patients. METHODS: We conducted a comprehensive search of literature in the MEDLINE and EMBASE databases and Cochrane Library. Studies (till June 2018) to identify hip fracture clinical trials/comparative studies comparing alternative surgical approaches (PLA and DLA). We explored sources of heterogeneity and conducted pooled analyses when appropriate. RESULTS: 264 potentially eligible studies were identified of which 1 RCT, 3 prospective, 3 registry data and 5 retrospective studies were included. The RCT consisted performance and attrition bias. The mean MINORS score of the prospective/register studies was 17.3 (SD 3.5) and 13.8 (SD 1.9) of the 5 retrospective studies. The GRADE score for all the outcomes was very low. Due to the high and various types of biases across the included studies, we did not pool the data. None of studies assessed the activities of daily living functionality. 6 studies reported significantly more dislocations or reoperations due to dislocation in the PLA group, 6 other studies found no differences. DLA patients were more likely to develop abductor insufficiency leading to limping and more need for walking aids. The PLA patients tended to have better quality of life, less pain and more satisfaction compared to the DLA patients. CONCLUSION: Based on low-quality studies, PLA may be associated with more dislocations, but patients had less walking problems and a lower tendency to abductor insufficiency compared with DLA. Further clinical trials with methodology rigor are needed to determine which approach is more effective in terms of outcomes relevant to patients.

Trauma surgery by general surgeons: Still an option for proximal femoral fractures?

INTRODUCTION: Surgery for proximal femoral fractures in the Netherlands is performed by trauma surgeons, general surgeons and orthopaedic surgeons. The aim of this study was to assess whether there is a difference in outcome for patients with proximal femoral fractures operated by trauma surgeons versus general surgeons. Secondly, the relation between hospital and surgeon volume and postoperative complications was explored. METHODS: Patients of 18 years and older were included if operated for a proximal femoral fracture by a trauma surgeon or a general surgeon in two academic, eight teaching and two non-teaching hospitals in the Netherlands from January 2010 until December 2013. The combined endpoint was defined as reoperation or surgical site infection. Multivariate analysis was used to adjust for patient and fracture characteristics and hospital and surgeon volume. Categories for hospital volume were>170/year (high volume), 96-170/year (medium volume) and <96/year (low volume). RESULTS: In 4552 included patients 2382 (52.3%) had surgery by a trauma surgeon. Postoperative complications occurred in 276 (11.6%) patients operated by a trauma surgeon and in 258 (11.9%) operated by a general surgeon (p=0.751). When considering confounders in a multivariate analysis, surgery by trauma surgeons was associated with less postoperative complications (OR 0.746; 95%CI 0.580-0.958; p=0.022). Surgery in high volume hospitals was also associated with less complications (OR 0.997; 95%CI 0.995-0.999; p=0.012). Surgeon volume was not associated with complications (OR 1.008; 95%CI 0.997-1.018; p=0.175). CONCLUSION: Surgery by trauma surgeons and high hospital volume are associated with less reoperations and surgical site infections for patients with proximal femoral fractures.