Subchondroplasty® Knee RCT
Condition: Bone Marrow Edema; Knee Pain Chronic; Knee Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      This is a multicenter, prospective, single-blinded, two-arm, randomized study. Enrolled
      subjects will have a single Bone Marrow Lesion of the tibia, single BML of the femur, or
      adjoining Bone Marrow Lesions of tibia and femur. Subjects will also be surgical candidates
      for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis.

      A stratified blocked randomization will be used to assign subjects to either Subchondroplasty
      with arthroscopy or to arthroscopy alone in a 2:1 ratio. Individual sets of blocks will be
      determined within study site and lesion polarity status (unipolar vs. bipolar).

      Subjects will be enrolled within 60 days prior to surgery and take part in follow-up visits
      for two years following surgery. A preoperative visit will occur at the time of enrollment.
      Follow-up visits were to initially occur at the study site at 6 weeks, 3 months, 6 months, 12
      months, and 24 months post-surgery. Telephone follow-up interviews to be be performed at 9
      and 18 months post-surgery. Target enrollment was 201 subjects, to include 134 subjects in
      the treatment group (Subchondroplasty + Arthroscopy) and 67 subjects in the control group
      (Arthroscopy alone).

      As of October 2020, follow-up has been amended to be completed remotely, where all visits can
      be performed electronically and/or via telephone.

      Subjects will complete the study at the 24 month follow-up visit. For the purposes of this
      protocol, a revision will be defined as any partial or total joint arthroplasty or any bone
      fixation, bone grafting or bone substitute procedure in the same compartment in the study
      knee.
    

Intervention name(s): Subchondroplasty with Arthroscopy; Arthroscopy Alone
Intervention type(s): Procedure; Procedure
Intervention description(s): The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.; An endoscopic examination, therapy and surgery of the knee joint.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A stratified blocked randomization will be used to assign subjects to either Subchondroplasty with arthroscopy or to arthroscopy alone in a 2:1 ratio. Individual sets of blocks will be determined within study site and lesion polarity status (unipolar vs. bipolar).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Subchondroplasty; Arthroscopy; Bone Substitute Material; Subchondral Bone Defect; AccuFill; Bone Marrow Lesion; Knee Replacement; Knee Replacement Alternative