Fully constrained acetabular liner vs. dual mobility hip joint in the surgical treatment of metastatic bone disease of the hip: study protocol for a randomized, open-label, two-arm, non-inferiority trial evaluating the post-operative hip dislocation rate

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Background
Patients receiving total hip arthroplasty (THA) due to metastatic bone disease of the hip (MBD) are at an increased risk of post-operative joint dislocation compared to other populations. Different joint solutions have been developed with the purpose of reducing the dislocation risk compared to regular THAs. One of these solutions, the constrained liner (CL), has been used increasingly at our department in recent years. This design, however, is prone to polyethylene wear and higher revision rates. An alternative is the dual mobility cup (DM), which has been shown to reduce the risk of dislocation in other high-risk populations. Few studies have investigated DM for THA due to MBD, and no studies have directly compared these two treatments in this population. We therefore decided to conduct a trial to investigate whether DM is non-inferior to CL regarding the post-operative joint dislocation risk in patients receiving THA due to MBD.

Materials and methods
This study is a single-center, randomized, open-label, two-arm, non-inferiority trial. We will include 146 patients with MBD of the hip who are planned for THA at the Department of Orthopedic Surgery, Rigshospitalet. Patients with previous osteosynthesis or endoprosthetic surgery of the afflicted hip, or who are planned to receive partial pelvic reconstruction or total femoral replacement, will be excluded. Patients will be stratified by whether subtrochanteric bone resection will be performed and allocated to either CL or DM in a 1:1 ratio. The primary outcome is the 6 months post-operative joint dislocation rate. Secondary outcomes include overall survival, implant survival, the rate of other surgical- and post-operative complications, and quality of life and functional outcome scores.

Discussion
This study is designed to investigate whether DM is non-inferior to CL regarding the risk of post-operative dislocation in patients receiving THA due to MBD. To our knowledge, this trial is the first of its kind. Knowledge gained from this trial will help guide surgeons in choosing a joint solution that minimizes the risk of dislocation and, ultimately, reduces the need for repeat surgeries in this patient population.
OriginalsprogEngelsk
Artikelnummer204
TidsskriftTrials
Vol/bind24
Udgave nummer1
Antal sider7
ISSN1745-6215
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
All the collected data will remain confidential. All participants will receive a subject ID for identification purposes. All personal and study-related information will be stored in protected servers and a REDCap database maintained by the Capital Region of Copenhagen. Project-related digital folders and the REDCap database is only visible and accessible to authorized research staff that has been granted access. Publication activities will be undertaken responsibly and ethically to ensure that all relevant information is communicated clearly and in a timely manner. Per current Good Publication Practice, we will submit for publication the results of the current study, primarily in peer-reviewed journals, or as abstracts, posters, or other presentations at scientific meetings. Results will be published irrespective of whether they are positive, negative or inconclusive. Publications will be prepared in accordance with the guidelines established by the International Committee of Medical Journal Editors (ICMJE). Thus, we are committed to ensuring that authorship for all publications complies with the criteria developed by the ICMJE. Version 2, July 19, 2022.

Publisher Copyright:
© 2023, The Author(s).

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