Study protocol: Effectiveness of dual-mobility cups compared with uni-polar cups for preventing dislocation after primary total hip arthroplasty in elderly patients - design of a randomized controlled trial nested in the Dutch Arthroplasty Registry.

Background and purpose - Dislocation is the leading reason for early revision surgery after total hip arthroplasty (THA). The dual-mobility (DM) cup was developed to provide more stability and mechanically reduce the risk of dislocation. Despite the increased use of DM cups, high-quality evidence of their (cost-)effectiveness is lacking. The primary objective of this randomized controlled trial (RCT) is to investigate whether there is a difference in the number of hip dislocations following primary THA, using the posterolateral approach, with a DM cup compared with a unipolar (UP) cup in elderly patients 1 year after surgery. Secondary outcomes include the number of revision surgeries, patient-reported outcome measures (PROMs), and cost-effectiveness.Methods and analysis - This is a prospective multicenter nationwide, single-blinded RCT nested in the Dutch Arthroplasty Registry. Patients ≥ 70 years old, undergoing elective primary THA using the posterolateral approach, will be eligible. After written informed consent, 1,100 participants will be randomly allocated to the intervention or control group. The intervention group receives a THA with a DM cup and the control group a THA with a UP cup. PROMs are collected preoperatively, and 3 months, 1 and 2 years postoperatively. Primary outcome is the difference in number of dislocations between the UP and DM cup within 1 year, reported in the registry (revisions), or by the patients (closed or open reduction). Data will be analyzed using multilevel models as appropriate for each outcome (linear/logistic/survival). An economic evaluation will be performed from the healthcare and societal perspective, for dislocation and quality adjusted life years (QALYs).Trial registration - This RCT is registered at www.clinicaltrials.gov with identification number NCT04031820.