NCT04090359 · Rush University Medical Center
Dual Mobility Acetabular Cups in Revision TJA
What this study is about
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.
View original scientific 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
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 3 months
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 2 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 5 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 10 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 15 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 20 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
- Philadelphia, Pennsylvania
Collaborators
Rothman Institute Orthopaedics, Keck School of Medicine of USC, NYU Langone Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations