Early Feasibility Study of Cartilage Defect Repair (NCT06823089) | Clinical Trial Compass
RecruitingNot Applicable
Early Feasibility Study of Cartilage Defect Repair
United States15 participantsStarted 2025-11-06
Plain-language summary
Any patient aged 14 or older up to 64 years of age with hip disease, resulting in loss of articular cartilage integrity on the femoral head (e.g., femoroacetabular impingement or other structural deformity), has failed conservative care, and is a candidate for surgical intervention to treat.
Who can participate
Age range
14 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. BMI \< 35
. Failed at least 6 weeks of conservative treatment (e.g., anti-inflammatory pain medications, physical therapy, injections)
. 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)
. 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
. Radiographic assessment with joint space width \> 2 mm (verified by x-ray)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To establish initial safety (adverse events and device related serious adverse events) and effectiveness (pain and function) of the ReNew Hip Implant
. Meets an acceptable preoperative medical clearance and is free of conditions that would pose excessive operative risk, in the opinion of the investigator
. Given consent to participate in the study
Exclusion criteria
. 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.
. Type 1 or Type 2 Diabetes
. Systemic steroid use in the 3 months prior to screening
. Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head that would result in implant mismatch of the femoral head contour
. Any acute or chronic condition that would limit the ability of the patient to participate in the study (e.g., COPD, congestive heart failure),
. Bleeding disorders
. Current cancer (with the exception of non-melanoma skin cancer)
. Pregnancy or planning to become pregnant during the study period