Status:

RECRUITING

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

Lead Sponsor:

JointMedica Inc.

Conditions:

Osteoarthritis of the Hip

Degenerative Joint Disease of Hip

Eligibility:

All Genders

21-65 years

Phase:

NA

Brief 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 ar...

Detailed Description

The PHR® System is a single-use device consisting of a Cobalt Chromium, bone-cemented femoral head component, and a cementless acetabular component comprising of a Vitamin E polyethylene (Vit E-XPE) b...

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

Key Trial Info

Start Date :

January 22 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2028

Estimated Enrollment :

238 Patients enrolled

Trial Details

Trial ID

NCT06792539

Start Date

January 22 2025

End Date

January 1 2028

Last Update

October 30 2025

Active Locations (10)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (10 locations)

1

Florida Medical Clinic Orlando Health

Tampa, Florida, United States, 33613

2

Rush University Medical Center

Chicago, Illinois, United States, 60612

3

Sinai Hospital / LifeBridge Health

Baltimore, Maryland, United States, 21215

4

NYU Longone

New York, New York, United States, 10003