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New hip implant aims to fix cartilage without replacement
NCT ID NCT06823089
First seen Jun 24, 2026 · Last updated Sep 17, 2026 · Updated 4 times
Summary
This early study is testing a new device called the ReNew Hip Implant in 15 people aged 14 to 64 with hip cartilage damage from conditions like osteoarthritis or hip impingement. The implant is surgically placed to repair the cartilage. Researchers are checking if it is safe and if it improves pain and hip function. This is a very early step, so results will show only if the device is promising enough for larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ReNew Hip Implant (a device surgically implanted to repair cartilage defects)
- What this could lead to
- If successful, this implant could offer a new surgical option to repair hip cartilage, potentially delaying or avoiding hip replacement.
- What could go wrong
- This is a very early, small study (15 people) focused on safety. The implant may fail, cause complications, or not improve symptoms. Long-term benefits 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
-
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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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
-
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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14 to 64 years
- Sex
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Anyone
- Healthy volunteers
-
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.
Inclusion Criteria: 1. At least 14 years of age to no older than 64 years of age Subjects 14-21 years of age must have radiographic evidence of epiphyseal closure in the hip joint 2. BMI \< 35 3. Failed at least 6 weeks of conservative treatment (e.g., anti-inflammatory pain medications, physical therapy, injections) 4. Duration of symptoms consistent with intra-articular disease (i.e., groin, lateral and/or posterior hip pain) that have persisted for at least 3 months) 5. Loss of articular cartilage integrity (\~1 - 6 cm\^2 in area) on the femoral head (confirmed by MRI), without an opposing lesion, that can be treated with a single ReNew Hip Implant 6. Radiographic assessment with joint space width \> 2 mm (verified by x-ray) 7. Meets an acceptable preoperative medical clearance and is free of conditions that would pose excessive operative risk, in the opinion of the investigator 8. Given consent to participate in the study 9. Able to understand the purpose of the study, his/her role, and is available for follow-up for the duration of the study: 1. Subject has signed an IRB (Institutional Review Board) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope, and possible consequences of the study have been explained in an understandable form 2. Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through five years post-operative follow-up Exclusion Criteria: 1. Current users of nicotine in any form (e.g., cigarettes, e- cigarettes/vaping, chewing tobacco, nicotine patches, gum, lozenges), or individuals who have discontinued nicotine use less than 30 days prior to screening. 2. Type 1 or Type 2 Diabetes 3. Systemic steroid use in the 3 months prior to screening 4. Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head that would result in implant mismatch of the femoral head contour 5. Any acute or chronic condition that would limit the ability of the patient to participate in the study (e.g., COPD, congestive heart failure), 6. Bleeding disorders 7. Current cancer (with the exception of non-melanoma skin cancer) 8. Pregnancy or planning to become pregnant during the study period 9. Active infection or sepsis 10. History of local hip infection 11. Known metastatic or neoplastic disease 12. Conditions that may interfere with implant survival or outcomes (e.g., severe dysplasia) 13. Life expectancy less than 2 years 14. Intra-articular therapy within 3 months of enrollment 15. Inadequate bone stock (as determined by SCORE or MORES assessment) to support the device 16. Femoral head is: 1. outside of the 46 - 56 mm range in either anteroposterior diameter or lateral diameters or 2. an aspherical head deformity that results in contour mismatch of 16a 17. Moderate to severe renal insufficiency 18. Emotional or neurological condition that would preempt ability or willingness to participate in the study 19. Above the knee amputation of the contralateral or ipsilateral leg 20. Known allergies to the components of the device (polycaprolactone) 21. Is a prisoner
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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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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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