Early Feasibility Study of Cartilage Defect Repair
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.
• 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)
• 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
• Able to understand the purpose of the study, his/her role, and is available for follow-up for the duration of the study:
‣ 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
⁃ 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