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NCT06792539 | RECRUITING | Osteoarthritis of the Hip

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

JointMedica Inc.

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 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.

Condition or disease

Osteoarthritis of the Hip

Degenerative Joint Disease of Hip

Dysplasia; Hip

Intervention/treatment

Polymotion Hip Resurfacing (PHR) System

Phase

NA

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) bearing with a titanium coating. The PHR® System is intended for patients who, due to their relatively younger age (under 65) and increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision. Hip Resurfacing Arthroplasty (HRA) is a surgery that has been developed as an alternative to Total Hip Arthroplasty (THA), especially for younger, more active patients. Studies done on past designs of HRA demonstrate the following noteworthy benefits of the HRA procedure when compared with THA: bone conservation, improved gait, higher activity levels, lower rates of dislocations, reduced thigh pain, and reduced alteration in leg length. Hip resurfacing restores the natural shape of the joint meaning better stability, longevity, and higher levels of activity than a traditional hip replacement. In Total Hip Replacement, the femoral head and neck (ball joint of the hip) is removed and replaced by a long, stemmed device. The procedure is highly successful; however, in some cases the replacement hip joint has the potential to wear out much more quickly in younger, more active patients, leading to revision surgery being required. With the PHR® procedure, your surgeon removes less bone from the femoral head of the femur and retains the femoral neck. The femoral head is shaped to accept a low-wear metal cap. This spherical cap closely matches your anatomy, reducing the risk of dislocation, and offering a broad range of movement and excellent stability. The acetabular socket (cup joint of the hip) is then fitted with a corresponding polyethylene component, significantly reducing potential reactions to metal ions associated with historic Metal-on-Metal hip resurfacing devices. A comprehensive range of sizes is offered to address the needs of most patients. Both components are designed to be implanted, to achieve reconstructive and functional replacement of the hip joint. The PHR® System is intended to offer the traditional benefits of hip resurfacing over total hip arthroplasties, such as bone conservation and restoration of natural biomechanics, without a metal-on-metal articulating surface.

Study Type : INTERVENTIONAL
Estimated Enrollment : 238 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Multi-Center, Prospective, Non-Randomized, Pivotal Trial Evaluating the Safety and Effectiveness of the Polymotion Hip Resurfacing System
Actual Study Start Date : 2025-01-22
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2028-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty

Location Details

NCT06792539

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Florida Medical Clinic Orlando Health

Tampa, florida, United States, 33613

RECRUITING

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

RECRUITING

United States, Maryland

Sinai Hospital / LifeBridge Health

Baltimore, Maryland, United States, 21215

RECRUITING

United States, New York

NYU Longone

New York, New York, United States, 10003

RECRUITING

United States, Ohio

Joint Implant Surgeons

New Albany, Ohio, United States, 43054

RECRUITING

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, South Carolina

Midlands Orthopaedics & Neurosurgery

Columbia, South Carolina, United States, 29210

RECRUITING

United States, Virginia

Hampton Road Orthopaedics

Newport News, Virginia, United States, 23606

RECRUITING

United States, Washington

Spokane Joint Replacement Center

Spokane, Washington, United States, 99218

RECRUITING

Bermuda, Trevelyan

Orthopaedic and Physiotherapy Associates

Paget, Trevelyan, Bermuda, DV04