Hyaluronic Acid vs Platelet Rich Plasma: Effects on Clinical Outcomes and Intra-articular Biology for the Treatment of Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      In this, prospective, double-blind study, patients with mild to moderate symptomatic knee
      osteoarthritis will be randomized to receive either a series of leukocyte poor, platelet-rich
      plasma or hyaluronic acid injections under ultrasound guidance. Clinical data in the form of
      subjective outcome measures will be collected pre-treatment and at four time intervals across
      a 1-year period. Synovial fluid will also collected for analysis of pro- and
      anti-inflammatory markers pre-treatment, and at 12 and 24 weeks.
    

Detailed description: 
      The objective of this double-blind prospective randomized clinical trial is to compare the
      effects of PRP to HA in patients with mild to moderate OA using biologic and clinical
      correlates of outcomes associated with the treatment of OA. The investigators will test the
      null hypothesis that there are no differences in clinical outcomes as measured by validated
      clinical scoring systems for OA, nor is there any difference in intra-articular biology
      between groups of patients treated with HA and those treated with PRP over time.

      This study was a prospective, randomized, double blind, comparative clinical trial with an
      allocation ratio of 1:1 that underwent IRB approval at the principal institution. Between
      2011 and 2014 patients will be screened for participation. All comers with a diagnosis of
      osteoarthritis of the knee between 18 and 80 years of age will be screened.

      Treatment and Evaluation Patients who meet inclusion criteria will be randomized via an
      electronic randomization process into two groups: one receiving intra-articular PRP and the
      other, intra-articular HA. Non-clinical staff will perform randomization, clinical staff
      performed the injections, and results and analyses will be performed by the primary research
      team. Patients and the primary research team performing analysis will be blinded to
      assignments. All patients will undergo a 10 ml blood draw for PRP preparation and a 3 ml
      peripheral blood draw for a complete blood count with leukocyte differential. This will be
      performed on patients who received HA to maintain patient blinding and to characterize the
      peripheral white blood cells (WBC) and platelet counts. A complete blood count (CBC) will be
      completed on PRP prior to injection to evaluate the fold increase in platelet concentration
      and to confirm rarity of red white blood cells. A synovial fluid aspirate of approximately
      2cc will be performed under ultrasound guidance just prior to each PRP or HA injection for
      ELISA analysis of basal and post-treatment intra-articular environment. After treatment,
      patients will be instructed to limit the use of the leg for at least 24 hours and use cold
      therapy/icing for discomfort. During this treatment period rest or mild exertion activities
      (such as exercise bike, aquatic therapy) are recommended, followed by gradual return to
      sports or recreational activities as tolerated.
    

Intervention name(s): Platelet-rich Plasma (PRP); Hyaluronic Acid
Intervention type(s): Biological; Biological
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: platelet-rich plasma; hyaluronic acid