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Evaluating a new hip resurfacing system compared to total hip replacement

A Multi-Center, Prospective, Non-Randomized, Pivotal Trial Evaluating the Safety and Effectiveness of the Polymotion Hip Resurfacing System

Not applicable Interventional JointMedica Inc. · NCT06792539

This study is testing a new hip resurfacing system to see if it works better than total hip replacement for adults with hip problems caused by arthritis or mild dysplasia.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment238 (estimated)
Ages21 Years to 65 Years
SexAll
SponsorJointMedica Inc. Academic / other
Locations11 sites (Tampa, Florida and 10 other locations)
Trial IDNCT06792539 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the Polymotion Hip Resurfacing (PHR) System in adults requiring hip resurfacing due to non-inflammatory arthritis or mild dysplasia. The PHR System features a unique design that conserves bone and may offer advantages over traditional total hip arthroplasty, particularly for younger, more active patients. Participants will undergo the PHR procedure and be monitored for outcomes related to joint function and recovery. The study will compare these outcomes to those of patients receiving total hip arthroplasty.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 65 with non-inflammatory arthritis or mild hip dysplasia requiring hip resurfacing.

Not a fit: Patients with severe bone quality issues or those over 65 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive and more effective option for younger patients needing hip surgery, potentially leading to better long-term outcomes.

How similar studies have performed: Previous studies on hip resurfacing have shown promising results, indicating that this approach may be beneficial for specific patient populations.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Tampa, Florida and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Osteoarthritis of the HipDegenerative Joint Disease of HipDysplasiaHiphip resurfacingdeterioration of hip cartilagePolymotion
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.