RecruitingPhase 4NCT04090359

Dual Mobility Acetabular Cups in Revision TJA


Sponsor

Rush University Medical Center

Enrollment

322 participants

Start Date

Sep 1, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria4

  • 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.

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Interventions

DEVICEDual Mobility Implant

Patients in this intervention will receive a dual mobility implant

DEVICEConventional, single-bearing implant

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


Locations(2)

New York University Medical Center

New York, New York, United States

Rothman Institute

Philadelphia, Pennsylvania, United States

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NCT04090359