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

NCT06792539 | Active Not Recruiting FDA Device

• 1 other identifier: CI001
• Study Type: interventional
• Target: 238
• Locations: 2 countries
• Sites: 9

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.

Conditions

Degenerative Joint Disease of Hip; Osteoarthritis of the Hip; Dysplasia; Hip

Keywords

hip resurfacing; Osteoarthritis of the Hip; deterioration of hip cartilage; Polymotion

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to evaluate the safety and clinical effectiveness of the Polymotion Hip Resurfacing System.

  The proportion of Polymotion subjects achieving Month-24 composite clinical success (CCS) will be compared to a propensity-score matched total hip arthroplasty control group collected from Rush University Medical Center, with the goal of demonstrating non-inferiority. Composite clinical success will be analyzed via Harris Hip Scores measuring pain, activity, and function, absence of device subsidence, progressive radiolucencies, osteolysis or migration through radiographic assessment, and the absence of serious safety events (secondary surgical interventions for the index hip or serious device-related adverse events).

  24 months

Secondary Outcomes (6)

• Harris Hip Score, and sub-scores of HHS for pain and function

  24 months

• SUSHI-University of California Los Angeles (UCLA) Activity Scores

  24 months

• Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS JR), and sub-scores of HOOS JR for pain and function

  24 months

• Forgotten Joint Score

  24 months

• SF-12

  24 months

Study Arms (1)

Polymotion Hip Resurfacing (PHR) System

EXPERIMENTAL

The investigational device, Polymotion Hip Resurfacing System ("Polymotion" or "PHR"), is a metal-onpolyethylene hip resurfacing device consisting of a metallic femoral component and an acetabular component made of Vitamin E HXLPE with a titanium coating on its bone-contacting surface. Both components are designed to be permanently 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 arthroplasty, such as bone conservation and restoration of natural biomechanics, without a metal-on-metal articulating surface.

Device: Polymotion Hip Resurfacing (PHR) System

Interventions

Polymotion Hip Resurfacing (PHR) System DEVICE

Surgical

Polymotion Hip Resurfacing (PHR) System

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• JointMedica Inc.: lead

Study Sites (9)

Florida Medical Clinic Orlando Health

Tampa, Florida, 33613, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Sinai Hospital / LifeBridge Health

Baltimore, Maryland, 21215, United States

Location

NYU Longone

New York, New York, 10003, United States

Location

Joint Implant Surgeons

New Albany, Ohio, 43054, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Midlands Orthopaedics & Neurosurgery

Columbia, South Carolina, 29210, United States

Location

Hampton Road Orthopaedics

Newport News, Virginia, 23606, United States

Location

Orthopaedic and Physiotherapy Associates

Paget, Trevelyan, DV04, Bermuda

Location

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Related Links

• Osteoarthritis.
• Related Info

MeSH Terms

Conditions

Osteoarthritis, Hip; Hip Dislocation

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Joint Dislocations; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Michael Mont, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, prospective, non-randomized, propensity score-adjusted, pivotal study

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 24, 2025
• Study Start: January 22, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); US (8)