What this study is
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.
What's being tested
- Dual Mobility Implant
Intervention · DEVICE
Patients in this intervention will receive a dual mobility implant
- Conventional, single-bearing implant
Intervention · DEVICE
Patients in this intervention will receive a conventional, single-bearing implant
Study details
- Sponsor
- Rush University Medical Center
- Conditions
- Dislocation, Hip
- Enrolling
- 322 people
- Starts
- 2017-09-01
- Est. completion
- 2036-11-01
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openNew York University Medical Center
New York, New York, United States
- Ran Schwarzkopf, MD · ContactRan.Schwarzkopf@nyumc.org
- Daniel Warren · Contactdaniel.warren@nyumc.org
Not yet recruitingRothman Institute
Philadelphia, Pennsylvania, United States
- Max Courtney, MD · Contactp.maxwell.courtney@rothmanortho.com
- William Li, BA · Contactwilliam.li@rothmanortho.com
- Javad Parvizi, MD · Principal investigator
Recruiting
Study team
Sponsor
Rush University Medical Center
Study ID 17022801
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.