This is a multi-center, prospective, single-blinded, two-arm study, randomized to include approximately 134 subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy alone.
The primary objective of this study is to demonstrate superiority of Subchondroplasty with arthroscopy compared to arthroscopy alone for treatment of Bone Marrow Lesions (BMLs) in the knee.
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion criteria
âś“. Voluntary signature of the Institutional Review Board/Research Ethics Board approved Informed Consent,
âś“. Male or female subjects between the ages of 30 to 75 years,
✓. Body Mass Index ≤ 40 (BMI=kg/m2),
âś“. Has experienced pain in study knee for at least 3 months,
âś“. Kellgren-Lawrence grade 1-3 Osteoarthritis, as reviewed on preoperative XR imaging, in the study knee,
âś“. BML is confirmed on T2 weighted or Proton Density MR Imaging by presence of white signal,
âś“. 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,
âś“. Surgical candidate for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis,
Exclusion criteria
âś•. BML caused by acute trauma less than 3 months prior to enrollment,
âś•. Clinical and/or radiographic disease diagnosis of the index knee that includes any of the following:
âś•. Kellgren-Lawrence Grade 4 Osteoarthritis with complete loss of joint space (bone-on-bone) or subchondral bone collapse,
âś•. Rheumatoid arthritis, or history of septic or reactive arthritis,
What they're measuring
1
Composite Clinical Success
Timeframe: Superiority will be statistically tested at month 12 at p<0.01