Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair
Condition: Defect of Articular Cartilage; Cartilage Injury; Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee; Fractures, Stress
Study type: Interventional

Summary: 
      This is a proof-of-concept study to determine the safety and efficacy of a novel device to
      increase the reparative capacity of the knee. The discovery of a resident population of
      mesenchymal stem cells (MSCs) within synovial fluid (SF) was the first description of this
      reparative cell population having direct access to superficial cartilage and joint
      structures. The ready access of SF MSC to cartilage and other joint tissues offers a novel
      strategy for joint repair. Current arthroscopic procedures result in the removal of all SF
      MSCs due to continuous irrigation throughout the procedure. The current study would benefit
      the patient by greatly increasing the reparative capacity of the joint by bolstering MSC
      numbers and retaining those MSCs within the joint after surgery. By accessing MSCs from the
      synovium it is anticipated that these cells would be entrapped/migrate into the marrow clot
      formed by microfracture of the sub-chondral bone. These MSCs would supplement those from the
      marrow and may result in faster, better quality repair.
    

Detailed description: 
      The synovium is a rich source of potent chondrogenic mesenchymal stromal cells (MSCs).
      Gaining access to this valuable source of regenerative cells could improve the outcome of
      joint restorative procedures. To avoid costly two-stage procedures and ex vivo manipulation,
      exploiting these autologous cells in a minimally invasive way with minimal manipulation could
      provide a novel cost-effective approach.

      This study will evaluate the safety, feasibility and efficacy of a novel medical device (a
      synovial brush) and procedure (synovial brushing) to increase the number of autologous
      minimally manipulated MSCs in the knee. Twenty patients undergoing microfracture for isolated
      chondral defects will be randomly assigned to either a control group (microfracture only, 10
      patients) or the intervention group (microfracture plus synovial brushing, 10 patients). The
      device is intended to increase the number of MSCs within the joint as a final stage during
      surgery, aiding repair by bolstering those MSCs recruited from the bone marrow.
    

Intervention name(s): Arthroscopic synovial brushing; Microfracture
Intervention type(s): Device; Procedure
Intervention description(s): The specific and novel surgical procedure that will be carried out here is synovial membrane brushing using a novel device that has been shown to release MSCs from the synovium in vitro. This technique will be carried out in the setting of therapeutic microfracture for cartilage defects.; Microfracture or marrow-stimulation is a surgical procedure to repair small isolated cartilage defects by recruiting bone marrow mesenchymal stromal cells by creating small holes ('micro fractures') in the sub-chondral bone. These cells are entrapped in the ensuing blood clot and contribute to partial repair of the cartilage.
Other intervention name(s): Marrow-stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cartilage; Mesenchymal stromal cell; Microfracture; Knee; Defect; Injury; Stem cell; Autologous; Minimally manipulated