Subchondroplasty® Knee RCT

Inclusion Criteria: * Candidates must meet ALL of the following: 1. Voluntary signature of the Institutional Review Board/Research Ethics Board approved Informed Consent, 2. Male or female subjects between the ages of 30 to 75 years, 3. Body Mass Index ≤ 40 (BMI=kg/m2), 4. Has experienced pain in study knee for at least 3 months, 5. Kellgren-Lawrence grade 1-3 Osteoarthritis, as reviewed on preoperative XR imaging, in the study knee, 6. BML is confirmed on T2 weighted or Proton Density MR Imaging by presence of white signal, 7. Single BML of tibia, single BML of femur, or adjoining BML's of tibia \& femur, in the same compartment, extending to the articular surface of the joint, 8. Surgical candidate for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis, 9. Must record a response, at the preoperative study visit, of moderate to extreme pain for any one of the KOOS Pain Scale questions, P2 through P9, 10. Index knee alignment is defined radiographically as one of the following: Neutral, ≤ 6° mechanical varus, or ≤ 6° mechanical valgus, 11. Ligaments in the study knee are stable, 12. The contralateral (non-study) knee is stable and functional, 13. Is refractory to conservative non-surgical management 1. having failed 2 or more of the following: hyaluronic acid injection, corticosteroid injection, NSAIDs, physical therapy, bracing, activity modification, or minimal surgical intervention (e.g., arthroscopy, debridement/chondroplasty, and/or loose body removal) 2. and is ≥ 3 months from the start of treatment, 14. Must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol - including all follow-up visits, survey completion, weight-bearing restrictions, and post-operative rehabilitation. Exclusion Criteria: * Candidates will be excluded if they meet ANY of the following: 1. BML caused by acute trauma less than 3 months prior to enrollment, 2. Clinical and/or radiographic disease diagnosis of the index knee that includes any of the following: 1. Kellgren-Lawrence Grade 4 Osteoarthritis with complete loss of joint space (bone-on-bone) or subchondral bone collapse, 2. Rheumatoid arthritis, or history of septic or reactive arthritis, 3. Gout or a history of gout or pseudogout in the affected knee, 4. Has more than two clinically relevant BMLs in the index knee, 5. Osteochondritis dissecans of the knee with significant bone loss, 6. Collapse of subc…