Dual Mobility Acetabular Cups in Revision TJA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2036-12-01

Brief Summary

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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.

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Detailed Description

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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

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Dislocation, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dual Mobility Implant

Intervention Type DEVICE

Patients in this intervention will receive a dual mobility implant

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.

Group Type ACTIVE_COMPARATOR

Conventional, single-bearing implant

Intervention Type DEVICE

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

Interventions

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Dual Mobility Implant

Patients in this intervention will receive a dual mobility implant

Intervention Type DEVICE

Conventional, single-bearing implant

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No