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

Study Overview
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Brief Summary
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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.

Official Title
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Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: platelet rich plasm
* Drug: Triamcinolone Hexacetonide
* Procedure: Isotonic Saline Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet rich plasm group<br> | Procedure: platelet rich plasm<br>* intra-articular infiltration with platelet rich plasm<br>|
| Active Comparator: Triamcinolone Hexacetonide group<br> | Drug: Triamcinolone Hexacetonide<br>* intra-articular infiltration withTriamcinolone Hexacetonide<br>|
| Placebo Comparator: Isotonic Saline Solution group<br> | Procedure: Isotonic Saline Solution<br>* intra-articular infiltration with Isotonic Saline Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Evaluated using a visual analogue scale | Baseline, after 4, 8, 12 and 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in joint edema | Evaluated using a visual analogue scale | Baseline, after 4, 8, 12 and 48 weeks | 
| Change in range of motion | Evaluated using goniometry | Baseline, after 4, 8, 12 and 48 weeks | 
| Change in a clinical improvement scale | Evaluated using an improvement scale | Baseline, after 4, 8, 12 and 48 weeks | 
| Change in quality of life | Using the SF-36 questionnaire | Baseline, after 4, 8, 12 and 48 weeks | 
| Change in functional capacity | Using the WOMAC questionnaire | Baseline, after 4, 8, 12 and 48 weeks | 
| Change in functional capacity | Using the M Lequesne questionnaire | Baseline, after 4, 8, 12 and 56 weeks | 
| Change in functional capacity | Using the six minute walk test | Baseline, after 4, 8, 12 and 48 weeks | 
| Change in functional capacity | Using the time to up and go test | Baseline, after 4, 8, 12 and 48 weeks | 
| Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler | Using an ultrasound exam | Baseline, after 4, 8, 12 and 48 weeks |