238 Participants Needed

Polymotion Hip Resurfacing for Hip Osteoarthritis

(PHR Trial)

Recruiting at 11 trial locations
SM
SK
Overseen BySharat Kusuma, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: JointMedica Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

MM

Michael Mont, MD

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 21 and 65 years old and my bones have stopped growing.
My bones are not strong enough to support a medical device.
I have bone tissue death due to lack of blood supply.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Polymotion Hip Resurfacing procedure

Surgical procedure with immediate post-operative care
1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments using Harris Hip Score and other measures

24 months
Regular follow-up visits (in-person and virtual)

Long-term follow-up

Participants continue to be monitored for long-term outcomes and device performance

Beyond 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Polymotion Hip Resurfacing (PHR) System
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Polymotion Hip Resurfacing (PHR) SystemExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

JointMedica Inc.

Lead Sponsor

Trials
1
Recruited
240+

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 ...
JointMedica 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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