Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial
Condition: Osteoarthritis, Knee; Microfragmented Adipose Tissue; Platelet-Rich Plasma
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The study aims to conduct a randomized trial comparing the clinical outcomes of PRP (standard
      intervention) versus Microfragmented adipose tissue (investigational) for the treatment of
      knee osteoarthritis.

      Hypothesis: Both interventions will result in significant improvement in patient-reported
      outcomes. We hypothesize that Microfragmented adipose tissue will provide superior outcomes.
    

Detailed description: 
      Background

      Knee osteoarthritis is a leading cause of disability worldwide. Standard of care treatments
      for knee OA include activity modification, weight loss, therapeutic exercise and injections
      like corticosteroids and viscosupplement. These commonly used non-operative treatments focus
      on symptom palliation, but are not disease modifying.

      Orthobiologics have emerged as a promising treatment for knee OA. The most widely studied
      orthobiologic is platelet-rich plasma (PRP). PRP is a dense concentration of platelets
      derived from autologous whole blood and platelets are concentrated 2-5x compared to baseline.
      The platelets have demonstrated anti-inflammatory and chondroprotective properties.6 PRP has
      been shown superior to placebo and viscosupplement for knee OA in several clinical trials.

      While PRP is the most widely studied and used orthobiologic, it contains only platelets.
      Therefore, a simple, office-based intervention able to collect additional reparative cells to
      treat knee OA would be ideal. Adipose (fat) is a known source of reparative cells like
      pericytes and it can be easily and safely aspirated in the clinic. The adipose tissue
      aspiration and processing is accomplished through a simple process. After local anesthesia to
      the site of adipose aspiration (lower abdomen or buttock), 30ml of adipose is aspirated
      through a cannula. That adipose is then processed in accordance with FDA guidelines including
      minimal manipulation to remove oils.. Using minimally manipulated Microfragmented adipose
      tissue has been shown safe for use as injection therapy for knee OA for 3 years.

      Methods:

      Patients / Outcome Measures / Sample size: Patients with unilateral symptomatic knee OA will
      be recruited from the sports medicine and orthopedics clinics, as well as advertising flyers
      within the clinic. All patients' first visit will include a medical evaluation and assess
      best treatment plan for that patient, regardless of candidacy for this study. This evaluation
      includes x-rays of their knees as a standard part of the evaluation. If they meet criteria
      and choose to enroll, they will be randomly assigned to either the PRP or Microfragmented
      adipose tissuetreatment group. Patients will complete follow up visits and surveys at defined
      time points through 12 months.
    

Intervention name(s): Platelet Rich Plasma
Intervention type(s): Device
Intervention description(s): Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Other intervention name(s): Microfragmented adipose tissue
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-treatment parallel-design
Masking: None (Open Label)
Primary purpose: Treatment