New hip device aims to delay full replacement
NCT ID NCT06792539
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a new hip resurfacing system in 238 adults with hip osteoarthritis or mild dysplasia. The device is designed to cap the damaged joint rather than replace the entire hip. Researchers will compare pain, function, and safety to standard total hip replacement over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Polymotion Hip Resurfacing (PHR) System (a surgical device)
- What this could lead to
- If successful, this could offer a less invasive hip replacement option that preserves more bone and may delay the need for a full hip replacement.
- What could go wrong
- This is a non-randomized trial, so results may be biased. The device is still being tested for safety and effectiveness, and long-term outcomes are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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238 people
The number who actually took part.
- Started
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Jan 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Florida Medical Clinic Orlando Health
Tampa, Florida, 33613, United States
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Hampton Road Orthopaedics
Newport News, Virginia, 23606, United States
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Joint Implant Surgeons
New Albany, Ohio, 43054, United States
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Midlands Orthopaedics & Neurosurgery
Columbia, South Carolina, 29210, United States
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NYU Longone
New York, New York, 10003, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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Orthopaedic and Physiotherapy Associates
Paget, Trevelyan, DV04, Bermuda
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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Sinai Hospital / LifeBridge Health
Baltimore, Maryland, 21215, United States
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