Early Feasibility Study of Cartilage Defect Repair
Cytex Therapeutics, Inc.
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.
Description
When patients suffer from arthritis in the hip joint and fail conservative treatment, the standard surgical approach is total joint arthroplasty, where the joint is entirely removed and replaced with artificial materials. While this procedure is suitable for less active or older individuals, it is not ideal for younger, more active patients. Despite this, the number of total hip replacements in younger patients is increasing, requiring significant lifestyle adjustments to extend the implant's lifespan. Even with these efforts, most patients will face at least one total joint revision in their…
Eligibility
- Age range
- 14–64 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceReNew Hip Implant
Surgical Intervention
Location
- Washington University School of MedicineSt Louis, Missouri