Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators include patients attending the outpatient clinic in the area of Orthopedics
      and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which
      treatment is medical. Patients will be divided into two groups. In both groups, they will be
      given verbal, clear and detailed information on the approach to follow, the intra-articular
      application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first
      group will be held single application, while in the second group three applications will be
      made at an interval of two weeks each. Both groups will be assessed before and after
      application, together with outpatient follow-up by the SF-12 Health Survey (SF-12), Western
      Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analogue Scale (VAS).
    

Detailed description: 
      Osteoarthritis (OA ) refers to a clinical syndrome of joint pain with a multifactorial
      etiology , with the gradual loss of articular cartilage, osteophytosis formation, subchondral
      bone remodeling and inflammation of the joint. Is the most common cause of knee pain, and one
      of the leading causes of disability and dependence of the adult population that generates
      large expenditures in the area of health.

      The clinical diagnosis of OA is primarily clinical - radiological, based on a complete
      medical history and physical examination directed. No laboratory studies are routinely
      requested since there is no specific diagnostic test or pathognomonic for diagnosis. Physical
      examination is most important.

      The ideal treatment is a multidisciplinary one, and must meet the objectives of achieving
      anesthesia, reduce disability and improve joint function and patient's quality life, with low
      toxicity of drugs. Several conservative treatments are recommended by clinical guidelines.
      Some nonpharmacologic measures are: patient education, exercise, weight loss, modification of
      footwear, using the local cryotherapy, acupuncture and electromagnetic therapy. Drug therapy
      can be summarized in paracetamol, NSAIDs, opioids, and slow-acting drugs. If these oral drugs
      do not work can be administered intra-articularly (corticosteroids, viscosupplementation
      products, and blood derivates).

      Platelet-Rich Plasma (PRP) is a rich source of growth factors such as Platelet-derived growth
      factor (PDGF), transforming growth factor β (TGF- β ), vascular endothelial growth factor
      (VEGF), like growth factor type I insulin (IGF- I), vascular endothelial growth factor (EGF),
      among others. For these growth factors are released, the platelets need to be activated by
      substances such as calcium chloride, calcium gluconate or thrombin. Once activated , growth
      factors are secreted, reaching a peak concentration 10 minutes. It is known that GF, PDGF and
      TGF -B stimulate chondrogenesis helping solving clinical manifestations of patients studied.

      The investigators include patients attending the outpatient clinic in the area of Orthopedics
      and Traumatology of our hospital with a diagnosis of knee osteoarthritis, which treatment is
      medical. Patients will be divided into two groups. In both groups, they will be given verbal,
      clear and detailed information on the approach to follow, the intra-articular application of
      Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first group will be
      held single application, while in the second group three applications will be made at an
      interval of two weeks each. Both groups will be assessed before and after application,
      together with outpatient follow-up by the SF-12, WOMAC and Visual Analogue Scale.

      The PRP would be obtained through previous an asepsis and antisepsis of the patient's arm,
      30cc of blood form the Basilic vein would be extracted.

      Each sample will initially centrifuged at 1800 rpm for 10 minutes in a centrifuge and the
      sample would be separated into three layers : 1- Red Cell (lower) White 2- (plasma rich in
      growth factors) Yellow 3- ( plasma poor in growth factors ).1000 ul PRP ( yellow layer ) is
      extracted by placing it in 15 mL Falcon tubes for subsequently performing a second step of
      centrifugation at 3400 rpm for 12 minutes. The top layer of platelet poor plasma is removed
      and stayed with the lower layer, the PRP (3-5 mL ) . Before application in the patient's
      knee,calcium gluconate 10% was added, 0.15 mL per milliliter of PRP obtained. The sample then
      would be aspirated with a 10 mL syringe for the application to the patient.

      After asepsis and antisepsis of where the puncture site , sterile drapes were placed clearing
      the workspace, the PRP is injected with a technique 45 ° at the corner superior- lateral
      patellar, reaching the joint capsule. Once injected the PRP, a sterile pad on the application
      area will be placed.
    

Intervention name(s): Platelet-Rich Plasma; rehabilitation exercises
Intervention type(s): Biological; Behavioral
Intervention description(s): Autologous Platelet-Rich Plasma will be applied by a intra-articular injections; Patients would been shown rehabilitation exercises, to perform them at home
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet-rich plasma; Osteoarthritis