Early Feasibility Study of Cartilage Defect Repair

Exclusion Criteria23

• 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
• Active infection or sepsis
• History of local hip infection
• Known metastatic or neoplastic disease
• Conditions that may interfere with implant survival or outcomes (e.g., severe dysplasia)
• Life expectancy less than 2 years
• Intra-articular therapy within 3 months of enrollment
• Inadequate bone stock (as determined by SCORE or MORES assessment) to support the device
• Femoral head is:
• outside of the 46 - 56 mm range in either anteroposterior diameter or lateral diameters or
• an aspherical head deformity that results in contour mismatch of 16a
• Moderate to severe renal insufficiency
• Emotional or neurological condition that would preempt ability or willingness to participate in the study
• Above the knee amputation of the contralateral or ipsilateral leg
• Known allergies to the components of the device (polycaprolactone)
• Is a prisoner