Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Tol MCJM

PROVIDER: S-EPMC9468978 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

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.

Tol Maria C J M MCJM Willigenburg Nienke W NW Willems Hanna C HC Gosens Taco T Rasker Ariena A Heetveld Martin J MJ Schotanus Martijn G M MGM Van Dongen Johanna M JM Eggen Bart B Kormos Mate M Van der Pas Stéphanie L SL Van der Vaart Aad W AW Poolman Rudolf W RW

Acta orthopaedica 20220912

<h4>Background and purpose</h4>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.<h4>Methods and analysis</h4>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 w ...[more]

PMID: 36097694

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Project description:ImportanceHip 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.ObjectiveTo 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 participantsThis 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.ExposureHemiarthroplasty using PLA or DLA.Main outcome and measuresThe 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.ResultsA 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 relevanceThis 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 registrationClinicalTrials.gov Identifier: NCT04438226.

Project description:ImportanceConsensus guidelines and systematic reviews have suggested that cemented fixation is more effective than uncemented fixation in hemiarthroplasty for displaced femoral neck fractures. Given that these recommendations are based on research performed outside the United States, it is uncertain whether these findings also reflect the US experience.ObjectiveTo compare the outcomes associated with cemented vs uncemented hemiarthroplasty in a large US integrated health care system.Design, setting, and participantsRetrospective cohort study of 12 491 patients aged 60 years and older who underwent hemiarthroplasty treatment of a hip fracture between 2009 and 2017 at 1 of the 36 hospitals owned by Kaiser Permanente, a large US health maintenance organization. Patients were followed up until membership termination, death, or the study end date of December 31, 2017.ExposuresHemiarthroplasty (prosthetic replacement of the femoral head) fixation via bony growth into a porous-coated implant (uncemented) or with cement.Main outcomes and measuresThe primary outcome measure was aseptic revision, defined as any reoperation performed after the index procedure involving exchange of the existing implant for reasons other than infection. Secondary outcomes were mortality (in-hospital, postdischarge, and overall), 90-day medical complications, 90-day emergency department visits, and 90-day unplanned readmissions.ResultsAmong 12 491 patients in the study cohort who underwent hemiarthroplasty for hip fracture (median age, 83 years; 8660 women [69.3%]), 6042 (48.4%) had undergone uncemented fixation and 6449 (51.6%) had undergone cemented fixation, and the median length of follow-up was 3.8 years. In the multivariable regression analysis controlling for confounders, uncemented fixation was associated with a significantly higher risk of aseptic revision (cumulative incidence at 1 year after operation, 3.0% vs 1.3%; absolute difference, 1.7% [95% CI, 1.1%-2.2%]; hazard ratio [HR], 1.77 [95% CI, 1.43-2.19]; P < .001). Of the 6 prespecified secondary end points, none showed a statistically significant difference between groups, including in-hospital mortality (1.7% for uncemented fixation vs 2.0% for cemented fixation; HR, 0.94 [95% CI, 0.73-1.21]; P = .61) and overall mortality (cumulative incidence at 1 year after operation: 20.0% for uncemented fixation vs 22.8% for cemented fixation; HR, 0.95 [95% CI, 0.90-1.01]; P = .08).Conclusions and relevanceAmong patients with hip fracture treated with hemiarthroplasty in a large US integrated health care system, uncemented fixation, compared with cemented fixation, was associated with a statistically significantly higher risk of aseptic revision. These findings suggest that US surgeons should consider cemented fixation in the hemiarthroplasty treatment of displaced femoral neck fractures in the absence of contraindications.

Dataset Information

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

Methods and analysis

Publications

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.

Similar Datasets

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