NCT04092634

Dual Mobility in "High Risk" Patients

Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 412 (estimated)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.

Detailed description

This study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single-bearing design. We hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts. Study Design: Randomized controlled trial with two groups: THA with dual mobility. 44 components vs THA with single-bearing designs

Conditions

• Dislocation, Hip

Interventions

Type	Name	Description
DEVICE	Dual mobility implant	Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant
DEVICE	Traditional, Single-bearing hip implant	Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant

Timeline

• Start date: 2017-11-01
• Primary completion: 2025-06-01
• Completion: 2035-02-01
• First posted: 2019-09-17
• Last updated: 2025-06-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study