Active — Not RecruitingNot Applicable

Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty

United States, Bermuda238 participantsStarted 2025-01-22

Plain-language summary

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, for adults who require hip resurfacing arthroplasty due to 1) non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, or 2) mild dysplasia/developmental dislocation of the hip (DDH) up to Crowe Grade 1.

Who can participate

Age range

21 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

In order to be eligible to participate in this study, subjects must meet all of the following criteria: 1. Requires primary hip resurfacing arthroplasty due to: 1. non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, or 2. mild dysplasia/developmental dislocation of the hip (DDH) up to Crowe Grade 1. 2. Harris Hip Score \< 70 points. 3. Skeletally mature, age ≥21 and \<65 years. 4. Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol. Subjects who meet any of the following criteria will be excluded from participating in this study: 1. Inadequate bone stock or bone quality to support the device based on a Canal-Bone Ratio (CBR-7) of \>0.45.0F 2. Severe osteopenia, a medical history or increased risk of severe osteoporosis or severe osteopenia, a history of fragility fracture, and other conditions that lead to increased bone resorption 3. Osteonecrosis or avascular necrosis (AVN) 4. Multiple cysts of the femoral head (\> 1cm) or cysts crossing the head-neck junction 5. Metabolic disorders which may impair bone formation (e.g., osteomalacia, osteogenesis imperfecta, parathyroid disease, rickets, etc.) 6. Severe femoral head deformities that will prevent fixation of the prosthetic resurfacing femoral head 7. Inflammatory arthritis such as rheumatoid art…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary objective of this study is to evaluate the safety and clinical effectiveness of the Polymotion Hip Resurfacing System.

Timeframe: 24 months

Trial details

NCT IDNCT06792539

SponsorJointMedica Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

View on ClinicalTrials.gov More Osteoarthritis of the Hip trials