Subchondroplasty® Knee RCT

Inclusion Criteria

• Candidates must meet ALL of the following:
• Voluntary signature of the Institutional Review Board/Research Ethics Board approved Informed Consent,
• Male or female subjects between the ages of 30 to 75 years,
• Body Mass Index ≤ 40 (BMI=kg/m2),
• Has experienced pain in study knee for at least 3 months,
• Kellgren-Lawrence grade 1-3 Osteoarthritis, as reviewed on preoperative XR imaging, in the study knee,
• BML is confirmed on T2 weighted or Proton Density MR Imaging by presence of white signal,
• 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,
• Surgical candidate for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis,
• 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,
• Index knee alignment is defined radiographically as one of the following: Neutral, ≤ 6° mechanical varus, or ≤ 6° mechanical valgus,
• Ligaments in the study knee are stable,
• The contralateral (non-study) knee is stable and functional,
• Is refractory to conservative non-surgical management
• 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)
• and is ≥ 3 months from the start of treatment,
• 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:
• BML caused by acute trauma less than 3 months prior to enrollment,
• Clinical and/or radiographic disease diagnosis of the index knee that includes any of the following:
• Kellgren-Lawrence Grade 4 Osteoarthritis with complete loss of joint space (bone-on-bone) or subchondral bone collapse,
• Rheumatoid arthritis, or history of septic or reactive arthritis,
• Gout or a history of gout or pseudogout in the affected knee,
• Has more than two clinically relevant BMLs in the index knee,
• Osteochondritis dissecans of the knee with significant bone loss,
• Collapse of subchondral bone,
• Clinically relevant BML located at ACL/PCL insertion,
• MRI evidence of frank ligament instability,
• Passive knee flexion 30°,
• History of systemic diseases which could contribute to secondary arthropathies (e.g., sickle cell disease, hemochromatosis, or autoimmune disease),
• Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,
• If diabetic, blood glucose over 200 mg/dL at time of enrollment,
• Current daily tobacco or high nicotine product user or < 3 months from nicotine cessation,
• Presents a high surgical risk due to unstable cardiac and/or pulmonary disease,
• Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint,
• Is at substantial risk for the need of organ transplantation, such as renal insufficiency,
• Is pregnant or breast-feeding at the time of surgery,
• Has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years,
• Has primary bone tumor in the knee area,
• Anticipates having a lower extremity surgery other than the investigational surgery during the course of the study,
• Is participating concurrently in another clinical trial, or has participated in