OR3O™ Dual Mobility System for Hip Osteoarthritis
(OR3O Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of the OR3O™ Dual Mobility System, a hip replacement device, in individuals undergoing total hip replacement. It will assess the device's performance over a ten-year period. The trial includes two groups: those receiving their first hip replacement and those requiring a revision to improve or fix a previous hip replacement. Suitable candidates include individuals with serious hip joint issues, such as arthritis or fractures, who need either their first or a follow-up hip replacement. As a Phase 4 trial, this research involves an FDA-approved treatment, providing participants the opportunity to benefit from an effective hip replacement while contributing to broader understanding.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that the OR3O™ Dual Mobility System is safe for Total Hip Arthroplasty?
Research has shown that the OR3O™ Dual Mobility System is safe. In one study on this hip implant, it performed well over two years, with low rates of joint instability and misalignment, indicating it is generally well-tolerated by patients undergoing their first hip replacement.
For those requiring a second hip replacement, another study found that this system might increase metal levels in the blood due to its materials. However, no serious side effects were directly linked to these increased levels.
Overall, the OR3O™ Dual Mobility System appears to be a safe choice for both first-time and repeat hip replacements, with a strong record of stability and few complications.12345Why are researchers enthusiastic about this study treatment?
The OR3O™ Dual Mobility System is unique because it offers enhanced stability and a lower risk of dislocation in hip arthroplasty, which sets it apart from traditional hip replacement options. Unlike standard hip replacements, which typically involve a single bearing surface, the OR3O™ system uses a dual mobility design, allowing for greater range of motion and reducing the likelihood of implant-related complications. Researchers are excited about this treatment because it has the potential to improve patient outcomes, especially in both primary and revision total hip arthroplasty procedures, by providing a more stable and durable joint solution.
What evidence suggests that the OR3O™ Dual Mobility System is effective for Total Hip Arthroplasty?
Research has shown that the OR3O™ Dual Mobility System yields promising results for both first-time and repeat hip replacement surgeries. In this trial, participants will receive the OR3O™ Dual Mobility System for either primary or revision total hip arthroplasty (THA). One study found that this new implant demonstrated excellent durability with a low risk of dislocation over two years. Specifically, it remained intact and functional in 99% of cases for up to four years in repeat surgeries. These findings suggest that the OR3O™ Dual Mobility System could be a good option for individuals needing hip replacements.12346
Who Is on the Research Team?
Ran Schwarzkopf, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Total Hip Arthroplasty using the OR3O™ Dual Mobility System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- OR3O™ Dual Mobility System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Smith & Nephew, Inc.
Lead Sponsor
Dr. Maria Berkman
Smith & Nephew, Inc.
Chief Medical Officer since 2023
MD from Harvard Medical School
Dr. Deepak Nath
Smith & Nephew, Inc.
Chief Executive Officer since 2022
PhD in Theoretical Mechanics, University of California, Berkeley