Polymotion Hip Resurfacing for Hip Osteoarthritis
(PHR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new hip resurfacing system, the Polymotion Hip Resurfacing (PHR) System, to determine its safety and effectiveness compared to traditional hip replacement surgery. It aims to assist individuals with specific types of arthritis or mild hip issues who have not undergone previous surgery. The trial seeks participants needing hip resurfacing due to conditions like osteoarthritis or mild hip dysplasia, which impact their daily lives.
As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance future hip treatments.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Polymotion Hip Resurfacing System is safe for hip resurfacing arthroplasty?
Research has shown that the Polymotion Hip Resurfacing (PHR) System aims to provide a safer and more effective option for hip replacements. Although detailed safety information from past studies is not readily available, the device is designed to enhance traditional hip resurfacing by combining metal and plastic. This design could reduce the risk of issues associated with older metal-only systems.
The trial is in a phase labeled "Not Applicable," focusing on safety and effectiveness. This typically indicates that the treatment has demonstrated some level of safety in earlier stages. However, since specific data from these studies is not provided, participants should stay informed and ask questions about any known side effects or risks before deciding to join the trial.12345Why are researchers excited about this trial?
The Polymotion Hip Resurfacing (PHR) System is unique because it combines a metal femoral component with an acetabular component made of Vitamin E-infused highly cross-linked polyethylene (HXLPE) with a titanium coating. This design aims to conserve more of the patient's natural bone compared to traditional total hip arthroplasty, which typically involves more extensive bone removal. Additionally, the PHR System avoids the metal-on-metal contact seen in some other hip resurfacing options, which can lead to complications. Researchers are excited about its potential to restore the natural biomechanics of the hip without the risks associated with metal-on-metal surfaces.
What evidence suggests that the Polymotion Hip Resurfacing System is effective for hip resurfacing arthroplasty?
Research has shown that the Polymotion Hip Resurfacing (PHR) System, which participants in this trial will receive, may offer advantages over traditional hip replacement. This system preserves more bone and maintains the hip's natural movement. It combines metal with a special plastic to potentially reduce wear and tear. Early results from other studies suggest that this method can effectively improve hip function for individuals with arthritis or mild hip problems. Although specific data on long-term success is still being collected, the design and materials used in this system have shown promise in other devices.12346
Who Is on the Research Team?
Michael Mont, MD
Principal Investigator
Principal Investigator
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 the Polymotion Hip Resurfacing procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments using Harris Hip Score and other measures
Long-term follow-up
Participants continue to be monitored for long-term outcomes and device performance
What Are the Treatments Tested in This Trial?
Interventions
- Polymotion Hip Resurfacing (PHR) System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The investigational device, Polymotion Hip Resurfacing System ("Polymotion" or "PHR"), is a metal-onpolyethylene hip resurfacing device consisting of a metallic femoral component and an acetabular component made of Vitamin E HXLPE with a titanium coating on its bone-contacting surface. Both components are designed to be permanently implanted, to achieve reconstructive and functional replacement of the hip joint. The PHR System is intended to offer the traditional benefits of hip resurfacing over total hip arthroplasty, such as bone conservation and restoration of natural biomechanics, without a metal-on-metal articulating surface.
Find a Clinic Near You
Who Is Running the Clinical Trial?
JointMedica Inc.
Lead Sponsor
Citations
Study Details | NCT06792539 | Evaluate the Safety and ...
The primary objective of this study is to evaluate the safety and clinical effectiveness of the Polymotion Hip Resurfacing System. The proportion of Polymotion ...
2.
jointmedica.com
jointmedica.com/latest-news/jointmedica-announces-launch-of-ide-study-for-polymotion-hip-resurfacing-systemJointMedica announces launch of IDE Study for Polymotion ...
The IDE study aims to evaluate the safety and clinical effectiveness of the Polymotion® Hip Resurfacing System to address the challenges faced ...
Evaluate the Safety and Effectiveness of the Polymotion Hip ...
The goal of this clinical trial is to evaluate the safety and effectiveness of the Polymotion Hip Resurfacing (PHR) System compared to total hip arthroplasty, ...
Clinical and Radiographic Outcomes of the JointMedica ...
The goal of this observational study is to generate Real World Evidence (RWE) on the device performance of the Polymotion Hip Resurfacing (PHR) ...
Evaluate the Safety and Effectiveness of the Polymotion ...
The goal of this clinical trial is to evaluate the safety and effectiveness of the Polymotion Hip Resurfacing (PHR) System compared to total hip arthroplasty.
JointMedica Polymotion Resurfacing Device Outcomes for ...
The goal of this observational study is to generate Real World Evidence (RWE) on the device performance of the Polymotion Hip Resurfacing (PHR) system and ...
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