Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.

• Status: Completed
• Trial end date: 2018-06-02
• Target enrollment: 0
• Participant gender: All

Summary

Osteoarthritis of the knee is a very prevalent disease. However, there are few therapeutic options for its patients. Platelet-rich plasma is a treatment option for chronic pain. If proven to be effective in its intra-articular use, Platelet-rich plasma may help in the treatment of these patients.

Goal:

Primary objective: To compare effectiveness in improving pain and function and the medium-term tolerance (12 weeks) of intra-articular injection of Platelet-rich plasma versus intraarticular injection of triamcinolone hexacetonide in patients with symptomatic primary knee osteoarthritis.

Secondary objective: To compare the medium-term effectiveness of intra-articular injection of Platelet-rich plasma versus intra-articular injection of triamcinolone hexacetonide to improve synovial hypertrophy and quality of life in these patients.

Methods: A prospective randomized controlled double-blind study with three groups (each with n = 33) of patients with symptomatic osteoarthritis of knees who will receive intra-articular infiltration in a single moment. Patients will be allocated to one of three groups: 1) Platelet-rich plasma group: patients who will receive plasma; 2) triamcinolone hexacetonide Group: patients who will receive 40mg of triamcinolone hexacetonide; And 3) Isotonic saline solution group: patients who will receive isotonic saline solution. The patients will be evaluated by "blind" evaluators in 4 assessment times up to 12 weeks of follow-up through clinical assessment instruments (rest and movement pain, joint edema, goniometry, clinical improvement scale, quality of life questionnaire as the SF36), functional (Womac questionnaire, M. Lequesne Functional Knee Index, 6 min walk test, Time up and go test), and ultrasound test (quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler).

Statistics: The following statistical tests will be used according to the need: Student's t test, Mann-whitney, Pearson's chi-square test and ANOVA for repeated measures. A statistical significance of 5% will be considered.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Treatments: Pharmaceutical Solutions; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• primary knee osteoarthritis

• degree II and II in Kellgren & Lawrence classification

• pain duration: more than three months

• pain in the visual analogue scale between 4 and 8cm

• agree in participate and sign the consent form

Exclusion Criteria:

• secondary knee osteoarthritis

• skin lesion in knee

• intraarticular joint injection in the previous three months

• steroids use in the previous 30 days

• degree I or IV in Kellgren & Lawrence classification

• inflammatory arthritis, gout and pseudo-gout

• cancer

• previous surgery in knee

• cardiovascular and respiratory disease that change functional status

• pregnancy and breastfeed

• coagulation disturb

• bacterial infection

• handicapped

• NSAIDs and Platelet anticoagulant in the previous month