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RecruitingOsteoarthritis, HipFemoroacetabular ImpingementOsteonecrosis

Early Feasibility Study of Cartilage Defect Repair

Eligible age

14–64 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Cytex Therapeutics, Inc.

You may qualify if…

  • ✓ 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

You may not qualify if…

  • ✕ 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

Where it's recruiting

Missouri

St Louis

Source: ClinicalTrials.gov · NCT06823089 · last updated 2026-02-17

Early Feasibility Study of Cartilage Defect Repair · TrialPath