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Clinical Trials/NCT04090359
NCT04090359
Recruiting
Phase 4

Dual Mobility Acetabular Cups in Revision TJA

Rush University Medical Center2 sites in 1 country322 target enrollmentSeptember 1, 2017

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Dislocation, Hip
Sponsor
Rush University Medical Center
Enrollment
322
Locations
2
Primary Endpoint
Prosthetic Dislocation
Status
Recruiting
Last Updated
last year

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
December 1, 2036
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Prosthetic Dislocation

Time Frame: 20 years

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

Secondary Outcomes

  • Routine radiographs assess for loosening and proper component placement(20 years.)
  • Complications(up to 20 years after the patient is discharged from the hospital)

Study Sites (2)

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