Study protocol: The DUALITY trial-a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients

Abstract

Background and purpose - Physically and mentally fit patients with a displaced femoral neck fracture (FNF) are mostly treated with total hip arthroplasty (THA). Dislocation is a severe and frequent complication in this group, and dual mobility cups (DMC) were developed to reduce the risk of dislocation after THA. The DUALITY trial investigates whether the use of DMC in FNF patients treated with a THA reduces the risk of dislocation.Patients and methods - The trial is a national, multicenter, register-based, randomized controlled trial (rRCT). Patients ≥ 65 years with a non-pathological, displaced FNF (Type Garden 3-4/AO 31-B2 or B3) who are suitable for a THA according to local guidelines are assessed for eligibility using the web-based registration platform of the Swedish Fracture Register (SFR). 1,600 patients will be randomized 1:1 to either insertion of a DMC (intervention group) or a standard cup (control group). The study is pragmatic in that the choice of implant brands, surgical approach, and peri- and postoperative protocols follow the local routines of each participating unit. All outcome variables will be retrieved after linkage of the study cohort obtained from the SFR with the Swedish Hip Arthroplasty Register and the National Patient Register.Outcomes - The primary outcome is the occurrence of any dislocation of the index joint treated with closed or open reduction within 1 year after surgery, expressed as a relative risk when comparing groups, and a risk reduction of at least 45% is considered clinically relevant. Secondary outcomes are the relative risk of any reoperation of the index joint, periprosthetic joint infection, and mortality within 90 days and 1 year. Patient-reported outcomes and health economics are evaluated.Start of trial and estimated duration - The DUALITY trial started recruiting patients in January 2020 and will continue for approximately 5 years.Trial registration - The trial is registered at clinicaltrials.gov (NCT03909815; December 12, 2019).