Dual Mobility Acetabular Cups in Revision TJA

NCT04090359 | Recruiting Phase 4 FDA Device

• 1 other identifier: 17022801
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (7)

• Prosthetic Dislocation

  The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  6 weeks

• Prosthetic Dislocation

  The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  3 months

• Prosthetic Dislocation

  The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  2 years

• Prosthetic Dislocation

  The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  5 years

• Prosthetic Dislocation

  The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  10 years

• Prosthetic Dislocation

  The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  15 years

• Prosthetic Dislocation

  The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  20 years

Secondary Outcomes (8)

• Complications

  up to 20 years after the patient is discharged from the hospital

• Routine radiographs assess for loosening and proper component placement

  6 weeks

• Routine radiographs assess for loosening and proper component placement

  3 months

• Routine radiographs assess for loosening and proper component placement

  2 years

• Routine radiographs assess for loosening and proper component placement

  5 years

Study Arms (2)

Dual Mobility

EXPERIMENTAL

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.

Device: Dual Mobility Implant

Conventional, Single-bearing hip implant

ACTIVE COMPARATOR

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.

Device: Conventional, single-bearing implant

Interventions

Dual Mobility Implant DEVICE

Patients in this intervention will receive a dual mobility implant

Dual Mobility

Conventional, single-bearing implant DEVICE

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

Conventional, Single-bearing hip implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Rothman Institute Orthopaedics: collaborator
• Keck School of Medicine of USC: collaborator
• NYU Langone Health: collaborator

Study Sites (2)

New York University Medical Center

New York, New York, 10003, United States

NOT YET RECRUITING

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

• Weintraub MT, DeBenedetti A, Nam D, Darrith B, Baker CM, Waren D, Schwarzkopf R, Courtney PM, Della Valle CJ. Dual-Mobility versus Large Femoral Heads in Revision Total Hip Arthroplasty: Interim Analysis of a Randomized Controlled Trial. J Arthroplasty. 2023 Jul;38(7S):S206-S210. doi: 10.1016/j.arth.2023.03.089. Epub 2023 Apr 3.

  PMID: 37019309 DERIVED

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Central Study Contacts

Craig Della Valle, MD

CONTACT

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

Anne DeBenedetti, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two groups: revision THA with dual mobility components vs revision THA with large head, single bearing designs (36mm and 40mm).

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 16, 2019
• Study Start: September 1, 2017
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2036
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)