Dual-Mobility vs Conventional Hip Implants for Hip Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two types of hip implants used in hip replacement surgeries: conventional implants and modular dual-mobility implants. The researchers aim to determine if dual-mobility implants increase metal levels in the blood, potentially affecting health. Participants will be divided into two groups, each receiving one type of implant. Ideal candidates are individuals with osteoarthritis who need hip replacement and are willing to have their blood tested after surgery. As a Phase 4 trial, this research involves FDA-approved treatments and helps to understand their benefits for more patients, offering participants a chance to contribute to improved healthcare outcomes.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications, but it does exclude patients taking chromium supplements. It's best to discuss your specific medications with the trial coordinators.
What is the safety track record for these treatments?
Research has shown that dual mobility hip implants are generally safe for patients. Studies indicate a low risk of problems, such as dislocation or the need for additional surgery. For instance, one study found that dual mobility implants performed well over two years, with few issues of instability. Another study found no difference in local complication rates compared to regular hip replacements, indicating similar short-term safety for both types.
Conventional hip implants also have a strong safety record. They have been used for many years and are considered a standard treatment. Research suggests that both dual mobility and conventional hip implants are well-tolerated and have comparable safety levels.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about dual-mobility hip implants because they offer a unique design compared to conventional hip implants. Traditional hip replacements typically use a single ball-and-socket joint, which can sometimes lead to dislocations or reduced range of motion. The dual-mobility design incorporates an additional polyethylene bearing that allows for greater movement and stability, potentially reducing the risk of dislocation. This innovation could improve outcomes for patients by providing more natural movement and enhancing the longevity of the implant, making it an attractive option for active individuals or those at higher risk of dislocation.
What evidence suggests that this trial's treatments could be effective for hip replacement?
This trial will compare dual mobility hip implants with conventional hip implants. Research has shown that dual mobility hip implants perform very well. Studies indicate they have a lower risk of dislocation compared to regular implants. For instance, one study found that these implants had a low risk of instability or dislocation after two years. Another study showed they performed better in revision surgeries. Overall, dual mobility implants are effective and reliable for hip replacements.12567
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with a BMI under 40 who need hip replacement surgery and are willing to have blood tests after the operation. It's not for those with prior hip infections, other metal implants (except dental), non-osteoarthritis diagnoses, poor kidney function, previous hip surgeries with metal devices, chromium supplement use, serious chronic diseases or expecting another joint surgery within a year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo primary total hip arthroplasty with either a modular dual mobility or conventional single-bearing component
Follow-up
Participants are monitored for serum metal levels and patient-reported outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Conventional cohort
- Dual mobility cohort
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
Zimmer Biomet
Industry Sponsor
Dr. Nitin Goyal
Zimmer Biomet
Chief Medical Officer since 2021
MD from Harvard Medical School
Ivan Tornos
Zimmer Biomet
Chief Executive Officer since 2023
MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business