Menu
Recruiting NCT04090359

Dual Mobility Acetabular Cups in Revision TJA

Phase IV Interventional Dislocation, Hip

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual Mobility Implant, Conventional, single-bearing implant.
Who it may be relevant to
Registry conditions: Dislocation, Hip. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Prosthetic Dislocation [Time frame: 6 weeks]
  • Prosthetic Dislocation [Time frame: 3 months]
  • Prosthetic Dislocation [Time frame: 2 years]
  • Prosthetic Dislocation [Time frame: 5 years]
  • Prosthetic Dislocation [Time frame: 10 years]
  • Prosthetic Dislocation [Time frame: 15 years]
  • Prosthetic Dislocation [Time frame: 20 years]
Secondary outcome measures (8)
  • Complications [Time frame: up to 20 years after the patient is discharged from the hospital]
  • Routine radiographs assess for loosening and proper component placement [Time frame: 6 weeks]
  • Routine radiographs assess for loosening and proper component placement [Time frame: 3 months]
  • Routine radiographs assess for loosening and proper component placement [Time frame: 2 years]
  • Routine radiographs assess for loosening and proper component placement [Time frame: 5 years]
  • Routine radiographs assess for loosening and proper component placement [Time frame: 10 years]
  • Routine radiographs assess for loosening and proper component placement [Time frame: 15 years]
  • Routine radiographs assess for loosening and proper component placement [Time frame: 20 years.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • New York University Medical Center — New York
  • Rothman Institute — Philadelphia

Publications

  • 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

Identifiers

NCT: NCT04090359 · 17022801

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗