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

Authors

  • Maria C J M Tol Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam
  • Nienke W Willigenburg Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam
  • Hanna C Willems Department of Internal Medicine and Geriatrics, Amsterdam UMC, Amsterdam https://orcid.org/0000-0002-3166-6951
  • Taco Gosens Department of Orthopedics and Trauma Surgery, ETZ, Tilburg; Department of Medical and Clinical Psychology, Tilburg University https://orcid.org/0000-0001-5805-3138
  • Ariena Rasker Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam https://orcid.org/0000-0002-1257-3012
  • Martin J Heetveld Department of Trauma Surgery, Spaarne Gasthuis, Haarlem
  • Martijn G M Schotanus Department of Orthopedic Surgery & Traumatology, Zuyderland Medical Center, Heerlen, Sittard-Geleen; School of Care and Public Health Research Institute, Faculty of Health, Medicine and Life Science, Maastricht University https://orcid.org/0000-0002-3975-6337
  • Johanna M van Dongen Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences Research Institute; Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam
  • Bart Eggen Delft University of Technology, Electrical Engineering, Mathematics and Computer Science, Delft
  • Mate Kormos Delft University of Technology, Electrical Engineering, Mathematics and Computer Science, Delft
  • Stéphanie L van der Pas Amsterdam UMC location Vrije Universiteit Amsterdam, Epidemiology and Data Science, Amsterdam; Amsterdam Public Health, Methodology, Amsterdam https://orcid.org/0000-0002-2448-5378
  • Aad W van der Vaart Delft University of Technology, Electrical Engineering, Mathematics and Computer Science, Delft
  • Rudolf W Poolman Department of Orthopedic Surgery, LUMC, Leiden, the Netherlands https://orcid.org/0000-0003-3178-2247
  • on behalf of the APOLLO research group

DOI:

https://doi.org/10.2340/17453674.2022.4547

Keywords:

Fractures, Hemiarthroplasty, Hip, Quality of Life, RCT, Surgical Approach

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.

Downloads

Download data is not yet available.

Published

2022-09-12

How to Cite

Tol, M. C. J. M., Willigenburg, N. W., Willems, H. C., Gosens, T., Rasker, A., Heetveld, M. J., Schotanus, M. G. M., van Dongen, J. M., Eggen, B., Kormos, M., van der Pas, S. L., van der Vaart, A. W., Poolman, R. W., & APOLLO research group, on behalf of the. (2022). 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. Acta Orthopaedica, 93, 732–738. https://doi.org/10.2340/17453674.2022.4547

Issue

Section

Study protocol, Registered report

Most read articles by the same author(s)