Recruiting

Dual Mobility

Sponsor:

Rush University Medical Center

Code:

NCT04090359

Conditions

Dislocation, Hip

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dual Mobility Implant

Conventional, single-bearing implant

Study Details

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.

Conditions

Dislocation, Hip

Study ID

NCT04090359

Start date

Sep 1, 2017

Status verified date

Apr, 2026

Completion date

Nov 1, 2036

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

322 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Dual Mobility

If patients are randomized to the dual mobility cohort, they will receive a dual mobility prosthesis at the surgeon's discretion. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.

active comparator: Conventional, Single-bearing hip implant

If patients are randomized to the conventional, single bearing cohort, surgeons will use their preferred implant design at their discretion using a 36 or 40mm head, depending on the diameter of the cup and manufacturer specifications. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.

Interventions

Dual Mobility Implant

Patients in this intervention will receive a dual mobility implant

Conventional, single-bearing implant

Patients in this intervention will receive a conventional, single-bearing implant

Primary outcome measure

  • Prosthetic Dislocation [ Time Frame: 6 weeks ]
  • Prosthetic Dislocation [ Time Frame: 3 months ]
  • Prosthetic Dislocation [ Time Frame: 2 years ]
  • Prosthetic Dislocation [ Time Frame: 5 years ]
  • Prosthetic Dislocation [ Time Frame: 10 years ]
  • Prosthetic Dislocation [ Time Frame: 15 years ]
  • Prosthetic Dislocation [ Time Frame: 20 years ]

Central Contacts and Locations

Central contacts

Craig Della Valle, MD

(312)432-2468craig.dellavalle@rushortho.com

Anne DeBenedetti, BA

(312)432-2468anne.debenedetti@rushortho.com

Locations

Rothman Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Max Courtney, MD

p.maxwell.courtney@rothmanortho.com

William Li, BA

william.li@rothmanortho.com

Principal Investigator:

Javad Parvizi, MD

More Information

Sponsor

Rush University Medical Center

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-05-05.