Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to … (NCT06792539) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty
United States238 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 range21 Years – 65 Years
SexALL
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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…
What they're measuring
1
The primary objective of this study is to evaluate the safety and clinical effectiveness of the Polymotion Hip Resurfacing System.