Dual Mobility Acetabular Cups in Revision TJA

Conditions

• Dislocation, Hip

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dual Mobility Implant — DEVICE
  Patients in this intervention will receive a dual mobility implant
• Conventional, single-bearing implant — DEVICE
  Patients in this intervention will receive a conventional, single-bearing implant

Study Details

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.

Key Dates

Start date

Sep 1, 2017

Status verified

Apr 2026

Primary completion

Nov 30, 2026

Completion

Nov 1, 2036

Study Design

Enrollment

322 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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.

Primary Outcome Measure

Prosthetic Dislocation [ Time Frame: 6 weeks ]

Central Contacts

• Craig Della Valle, MD
  (312)432-2468
  [email protected]
• Anne DeBenedetti, BA
  (312)432-2468
  [email protected]

Locations (2)

Find similar trials in New York, NY

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