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

Study protocol: The DUALITY trial-a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients. Acta Orthop. 2020 Jun 22;:1-8 Authors: Wolf O, Mukka S, Notini M, Möller M, Hailer NP, DUALITY GROUP 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...
Source: Acta Orthopaedica - Category: Orthopaedics Authors: Tags: Acta Orthop Source Type: research