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

April 27, 2026 updated by: JointMedica Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bermuda
    • Trevelyan
      • Paget, Trevelyan, Bermuda, DV04
        • Orthopaedic and Physiotherapy Associates
  • United States
    • Florida
      • Tampa, Florida, United States, 33613
        • Florida Medical Clinic Orlando Health
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital / LifeBridge Health
    • New York
      • New York, New York, United States, 10003
        • NYU Longone
    • Ohio
      • New Albany, Ohio, United States, 43054
        • Joint Implant Surgeons
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • Midlands Orthopaedics & Neurosurgery
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Hampton Road Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polymotion Hip Resurfacing (PHR) System

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
Surgical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective of this study is to evaluate the safety and clinical effectiveness of the Polymotion Hip Resurfacing System.
Time Frame: 24 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score, and sub-scores of HHS for pain and function
Time Frame: 24 months

The Harris Hip Score is used to measure pain severity, function, and absence of deformity.

Each hip joint is scored on nine parameters, generating a total score representing the severity of the condition. The lower the score the better. The minimum score for each hip is 0 and the maximum is 53, giving a range for the total score of 0 to 106.
24 months
SUSHI-University of California Los Angeles (UCLA) Activity Scores
Time Frame: 24 months
The SUSHI-UCLA Activity Score is a 10-item assessment of physical activity level to assess patients overall state, pain and limitations of their hip.
24 months
Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS JR), and sub-scores of HOOS JR for pain and function
Time Frame: 24 months
The HOOS JR Survey is a short form of the HOOS that assesses patient pain (2 items), and functions of daily living (4 items).
24 months
Forgotten Joint Score
Time Frame: 24 months
The Forgotten Joint Score consists of 12 questions, scored on a 0-100 scale, intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment.
24 months
SF-12
Time Frame: 24 months
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health.
24 months
Radiographic success
Time Frame: 24 months
Absence of migration, subsidence, and osteyloysis
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JointMedica Inc.

Investigators

  • Principal Investigator: Michael Mont, MD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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