Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
- Conditions
- Knee Osteoarthritis
- Interventions
- Registration Number
- NCT03086759
- Lead Sponsor
- Federal University of São Paulo
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Triamcinolone Hexacetonide group Triamcinolone Hexacetonide - Platelet rich plasm group platelet rich plasm - Isotonic Saline Solution group Isotonic Saline Solution -
- Primary Outcome Measures
Name Time Method Change in pain Baseline, after 4, 8, 12 and 48 weeks Evaluated using a visual analogue scale
- Secondary Outcome Measures
Name Time Method Change in functional capacity Baseline, after 4, 8, 12 and 48 weeks Using the time to up and go test
Change in joint edema Baseline, after 4, 8, 12 and 48 weeks Evaluated using a visual analogue scale
Change in range of motion Baseline, after 4, 8, 12 and 48 weeks Evaluated using goniometry
Change in a clinical improvement scale Baseline, after 4, 8, 12 and 48 weeks Evaluated using an improvement scale
Change in quality of life Baseline, after 4, 8, 12 and 48 weeks Using the SF-36 questionnaire
Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler Baseline, after 4, 8, 12 and 48 weeks Using an ultrasound exam
Trial Locations
- Locations (1)
Universidade Federal de Sao Paulo
🇧🇷Sao Paulo, SP, Brazil