Dual Mobility Acetabular Cups in Revision TJA

Phase 4

Recruiting

• Conditions: Dislocation, Hip

• Registration Number: NCT04090359
• Lead Sponsor: Rush University Medical Center

Brief Summary

The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.

Detailed Description

The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-03
• Study Completion: 2036-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 322

Inclusion Criteria

• Any patient older than 18 years of age scheduled for a revision THA, including revision of both components, conversion of a hip resurfacing to THA, conversion of a hemiarthroplasty to THA, and revision of single components which allow implantation of dual-mobility bearings. In addition, patients undergoing reimplantation of a total hip arthroplasty following a two-stage revision for periprosthetic infection will also be included. Only patients with an acetabular shell diameter capable of accommodating at least a 36mm femoral head will be included.

Exclusion Criteria

• Less than 18 years of age, primary THA,
• conversion of non-arthroplasty femoral neck fracture fixation to THA,
• patients unwilling to participate.
• patients where the surgeon makes the intraoperative decision to use a constrained liner will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prosthetic Dislocation	20 years	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

Secondary Outcome Measures

Name	Time	Method
Routine radiographs assess for loosening and proper component placement	20 years.	Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. Radiographics will be assessed for loosening in a yes/no way.
Complications	up to 20 years after the patient is discharged from the hospital	Any peri- or postoperative complications will be recorded, including component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates

Trial Locations

Locations (2)

New York University Medical Center; 🇺🇸 New York, New York, United States

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States