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

Launched by JOINTMEDICA INC. · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new device called the Polymotion Hip Resurfacing (PHR) System to see how safe and effective it is compared to traditional total hip replacement surgery. The study focuses on adults who need hip surgery due to conditions like osteoarthritis or mild hip dysplasia, which is a developmental issue. Researchers aim to understand if the PHR system can provide better outcomes for patients with these conditions.

To participate, individuals must be between 21 and 65 years old and have a specific score (Harris Hip Score) that indicates their hip function is limited. They should also be physically and mentally able to follow the study's guidelines. However, those with certain health issues, such as severe bone problems, inflammatory arthritis, or serious medical conditions like severe heart or kidney disease, will not be eligible. Participants will undergo the surgery and will need to attend follow-up visits to monitor their progress, helping researchers gather important information about the effectiveness of the new hip resurfacing system.

Gender

ALL

Eligibility criteria

• 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 arthritis (RA)
• • 8. Severe proximal femoral rotational deformity in whom appropriate combined anteversion of femoral-acetabular construct is unachievable
• • 9. Severe acetabular dysplasia/development dislocation of the hip, defined as Crowe Grade ≥ 2
• • 10. Previous surgical intervention on index hip (e.g., treatment of hip fracture, arthroscopy)
• 11. Severe medical comorbidities, including:
• • 1. severe cardiopulmonary disease,
• • 2. congestive heart failure,
• • 3. severe liver or kidney dysfunction,
• • 4. end-stage renal disease,
• • 5. severe uncontrolled diabetes,
• • 6. history of IV drug use,
• • 7. history of hypercoagulable state or pulmonary embolism,
• • 8. severe lumbar spinal stenosis,
• • 9. vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or post-operative recovery,
• • 10. neuropathic arthropathy (Charcot joint),
• • 11. immunosuppression or other immunodeficiency disorders, e.g., diseases such as Acquired Immune Deficiency Syndrome (AIDS) or post-organ transplant and on high doses of corticosteroids.
• • 12. Incompetent or deficient soft tissue surrounding the joint (e.g., hip abductor muscle deficiency)
• • 13. BMI \> 40
• • 14. Active or suspected infection in or around the hip joint
• • 15. Known or suspected metal sensitivity (e.g., jewelry) or allergy to any implant materials
• • 16. Pregnant or plan to become pregnant during the study duration
• • 17. Current smoker