Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Platelet rich plasm group
|
Procedure: platelet rich plasm
intra-articular infiltration with platelet rich plasm
|
| Active Comparator: Triamcinolone Hexacetonide group
|
Drug: Triamcinolone Hexacetonide
intra-articular infiltration withTriamcinolone Hexacetonide
|
| Placebo Comparator: Isotonic Saline Solution group
|
Procedure: Isotonic Saline Solution
intra-articular infiltration with Isotonic Saline Solution
|
Outcome Measures
Primary Outcome Measures
- Change in pain [Baseline, after 4, 8, 12 and 48 weeks]
Evaluated using a visual analogue scale
Secondary Outcome Measures
- 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
- Change in functional capacity [Baseline, after 4, 8, 12 and 48 weeks]
Using the WOMAC questionnaire
- Change in functional capacity [Baseline, after 4, 8, 12 and 56 weeks]
Using the M Lequesne questionnaire
- Change in functional capacity [Baseline, after 4, 8, 12 and 48 weeks]
Using the six minute walk test
- Change in functional capacity [Baseline, after 4, 8, 12 and 48 weeks]
Using the time to up and go test
- 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
Eligibility Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidade Federal de Sao Paulo | Sao Paulo | SP | Brazil | 04023900 |
Sponsors and Collaborators
- Federal University of São Paulo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CEP UNIFESP 842 167/2014