Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
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|ClinicalTrials.gov Identifier: NCT03086759|
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : January 18, 2019
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.
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|
|Knee Osteoarthritis||Procedure: platelet rich plasm Drug: Triamcinolone Hexacetonide Procedure: Isotonic Saline Solution||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee.|
|Actual Study Start Date :||January 2, 2017|
|Actual Primary Completion Date :||June 2, 2018|
|Actual Study Completion Date :||June 2, 2018|
|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
- Change in pain [ Time Frame: Baseline, after 4, 8, 12 and 48 weeks ]Evaluated using a visual analogue scale
- Change in joint edema [ Time Frame: Baseline, after 4, 8, 12 and 48 weeks ]Evaluated using a visual analogue scale
- Change in range of motion [ Time Frame: Baseline, after 4, 8, 12 and 48 weeks ]Evaluated using goniometry
- Change in a clinical improvement scale [ Time Frame: Baseline, after 4, 8, 12 and 48 weeks ]Evaluated using an improvement scale
- Change in quality of life [ Time Frame: Baseline, after 4, 8, 12 and 48 weeks ]Using the SF-36 questionnaire
- Change in functional capacity [ Time Frame: Baseline, after 4, 8, 12 and 48 weeks ]Using the WOMAC questionnaire
- Change in functional capacity [ Time Frame: Baseline, after 4, 8, 12 and 56 weeks ]Using the M Lequesne questionnaire
- Change in functional capacity [ Time Frame: Baseline, after 4, 8, 12 and 48 weeks ]Using the six minute walk test
- Change in functional capacity [ Time Frame: 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 [ Time Frame: Baseline, after 4, 8, 12 and 48 weeks ]Using an ultrasound exam
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086759
|Universidade Federal de Sao Paulo|
|Sao Paulo, SP, Brazil, 04023900|