A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea,

Exclusion Criteria

• •Have a Body Mass Index (BMI) \>35kg/m2
• •Have more than two lesions (ICRS grade 3 or 4A) on any surface in the index knee
• •Have "kissing" or opposing lesion(s) (ICRS grade 3 or 4A) of the condyle, tibia or patella in the index knee; additional linear lesions which bear Grade 3 or 4 characteristics may be acceptable if they are determined by the Investigator to be incidental, not clinically relevant, and consistent with the subject demographic
• •Have malalignment of \>5 degrees varus or valgus in the index knee based on standard AP x-rays requiring an osteotomy
• •Have had any surgical treatment for cartilage repair in the index knee within 1 year prior to treatment
• •Have had intra-articular injections within 3 months in the index knee
• •Have a diagnosis of a concomitant knee injury which may confound assessment of the index knee (e.g., important meniscal injury)
• •Have significant pain emanating from other lower body joints in the ipsilateral (hip, ankle) or contralateral (hip, knee, ankle) limb.
• •Have known allergies to shellfish
• •Have a known history of crystalloid or inflammatory arthropathy
• •Have any condition that is unrelated to the index knee and significantly impairs walking ability (e.g., spinal stenosis, sciatica)
• •Have advanced musculoskeletal disease
• •Have active coagulation disorders
• •Are currently using antibiotics
• •Are participating concurrently in another clinical investigation, or have participated in a clinical investigation within the last 90 days, or intend to participate in another clinical investigation during the course of the study
• •Are currently abusing drugs or alcohol or have a history of the same within the last 12 months
• •Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
• •Are currently breastfeeding or planning to breastfeed any time during the course of the study
• •Are currently a prisoner
• •Have significant comorbidities or conditions associated with high-risk for surgical or anesthetic survival (e.g., renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.)
• •Have any medical condition or other circumstances, in the judgment of the investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative rehabilitation
• •Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance
• •Subjects who meet any of the following intra-operative screening criteria will be excluded from participation in this study:
• •Have lesion(s) in the index knee that are not contained (intact shoulders) and/or exceed 7 cm² in total size after debridement for a single lesion and 10cm2 for more than one lesion, if within the same condyle or the trochlea. If only a single lesion suitable to be included is identified, it might be between 1-7cm2.
• •Minor concomitant procedures are allowed such as, but not limited to:
• •1. Removal of loose bodies
• •2. Plica excision
• •3. Minor synovial removing
• •4. Minor chondroplasty (debridement)
• •5. Lysis of adhesions