Subchondroplasty Procedure in Patients With Bone Marrow Lesions

Inclusion Criteria: * At least 18 years of age at time of screening * Patient with BML(s) in one or both knees, as diagnosed by the treating physician, willing and eligible to undergo the SCP Procedure * One or more BML(s) of the tibial plateau and/or femoral condyle extending to the articular surface of the joint confirmed on T2 weighted fat-suppressed or fat-suppressed Proton Density MR Imaging by presence of white signal * Patient's index knee alignment, which is defined radiographically, must be one of the following: Neutral, 6 degree mechanical varus, or 6 degree mechanical valgus * Patient is refractory to conservative non-surgical management of BML: * Having failed 2 or more of the following: hyaluronic acid (HA) injection, corticosteroid injection, non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy, bracing, or minimal surgical intervention (e.g. arthroscopy, debridement/chondroplasty, and/or loose body removal) * and diagnosis of BML is more than 3 months of the study treatment * Willing and able to comply with the study procedures * Signed an informed consent form approved by independent ethics committee (IEC) Exclusion Criteria: * Existing acute or chronic infections at the surgical site * Bone in the index knee is non-viable or not capable of supporting and anchoring the implant. * Known systemic disorders or any systemic inflammatory condition (e.g. rheumatoid arthritis) * Acute traumatic injuries with open wounds close to the bone defect wh…