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Randomized Controlled Trial
. 2024 Jan 2;7(1):e2350765.
doi: 10.1001/jamanetworkopen.2023.50765.

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

Maria C J M Tol  1 , Nienke W Willigenburg  1 , Ariena J Rasker  1 , Hanna C Willems  2 , Taco Gosens  3   4 , Martin J Heetveld  5 , Martijn G M Schotanus  6   7 , Bart Eggen  8 , Mate Kormos  8 , Stéphanie L van der Pas  9   10 , Aad W van der Vaart  8 , J Carel Goslings  11 , Rudolf W Poolman  1   12 ; APOLLO Research Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Maria C J M Tol et al. JAMA Netw Open. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Willems reported receiving personal fees from Union Chimique Belge and Amgen outside the submitted work. Dr van der Pas reported receiving grants from Nederlandse Organisatie voor Wetenschappelijk Onderzoek during the conduct of the study. Dr Poolman reported receiving grants from Link Lima and Landelijke Registratie Orthopedische Interventies outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Flow Diagrams
DLA indicates direct lateral approach; PLA, posterolateral approach; and RCT, randomized clinical trial.
Figure 2.
Figure 2.. EuroQol Group 5-Dimension (EQ-5D-5L) and EuroQol Visual Analog Scale (EQ-VAS) Outcomes
NE indicates natural experiment; RCT, randomized clinical trial.
Figure 3.
Figure 3.. Secondary Outcomes After 6 Months
ADL indicates activities of daily living; DLA, direct lateral approach; NE, natural experiment; PLA, posterolateral approach; and RCT, randomized clinical trial.
Figure 4.
Figure 4.. Fused Results of Primary and Secondary Outcomes
DLA indicates direct lateral approach; ED, emergency department; EQ-5D-5L, EuroQol Group 5-Dimension questionnaire; EQ-VAS, EuroQol Visual Analog Scale; FES-I, Falls Efficacy Scale International; NE, natural experiment; OR, odds ratio, PLA, posterolateral approach; and RCT, randomized clinical trial. Dotted line indicates 0 (A, B, and C) or 1.00 (D, E, F, and G).
See this image and copyright information in PMC

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