Effect of Different Injection Regimens of Autologous Conditioned Plasma for Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The clinical efficacy of hyaluronic acid or corticosteroid injections has been reported, but
      effects are short lived. This has led to the development of additional injection options such
      as autologous derived blood products which have been documented to alleviate symptoms related
      to knee osteoarthritis, with recent comparative studies suggesting a greater, long-lasting
      effect with these blood derived products like platelet rich plasma (PRP) [2-8]. One
      clinically-developed preparation of platelet rich plasma, named autologous conditioned plasma
      (ACP), has randomized controlled trial data proving efficacy [4,9]. Clinical use of platelet
      rich plasma for knee arthritis typically involves a 3-injection series over 3 weeks, i.e. an
      injection once a week for three weeks. The main objective of this study is to determine if
      hyaluronic acid (HA) injected at the same time as autologous conditioned plasma (ACP), a
      leukocyte-poor platelet rich plasma product, will improve the performance of ACP in the
      treatment of symptomatic knee osteoarthritis. It is hypothesized that the injection of
      hyaluronic acid will improve the efficacy of ACP.
    

Detailed description: 
      Patients between the ages of 30 and 80 who have documented radiographic evidence of OA in the
      tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence grades 1-4)
      will be screened for participation in this study. Patients must have a documented diagnosis
      of primary OA for at least six weeks. 80 patients will be recruited through the Andrews
      Institute physician practices. The study design will be a randomized control trial.
      Participants who meet the inclusion criteria will have the study explained in detail, and
      informed consent will be obtained as outlined above. Participants will complete
      patient-reported outcome questionnaires prior to their injection. The questionnaires will
      include the Western Ontario and McMaster University Osteoarthritis Index (WOMAC),
      International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC), Knee
      Injury and Osteoarthritis Outcome Score (KOOS). Participants will also complete these
      questionnaires at 1, 3, 6, 12, 18, and 24 months after the final injection. A trained medical
      professional will draw blood from the patient's arm, and the blood will be spun in a
      centrifuge for 5 minutes at 1500 RPM. The platelets will then be separated for injection into
      the patient's knee. The treating physician will then inject the ACP into the involved knee
      joint following standard aseptic technique per the physician's standard of care. This entire
      process will be completed in a single patient visit. Any unused portion of a sample in the
      physician's office will be disposed of through standard biohazard waste disposal systems as
      required by law. Group 1 [ACP]: Will receive three intra-articular injections of autologous
      conditioned plasma dosed once a week for three weeks. Group 2 [ACP-HA]: Will receive two
      intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week
      for two weeks and a third injection on the third week of ACP.
    

Intervention name(s): Hyaluronan; Autologous conditioned plasma
Intervention type(s): Drug; Biological
Intervention description(s): Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.; Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.
Other intervention name(s): Hymovis; Monovisc; Orthovisc
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment