Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
Status:
Completed
Trial end date:
2018-06-02
Target enrollment:
Participant gender:
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.