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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet rich plasm group | Experimental |
| |
| Triamcinolone Hexacetonide group | Active Comparator |
| |
| Isotonic Saline Solution group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platelet rich plasm | Procedure | intra-articular infiltration with platelet rich plasm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain | Evaluated using a visual analogue scale | Baseline, after 4, 8, 12 and 48 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Sao Paulo | São Paulo | São Paulo | 04023900 | Brazil |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C005900 | triamcinolone hexacetonide |
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| Triamcinolone Hexacetonide | Drug | intra-articular infiltration withTriamcinolone Hexacetonide |
|
| Isotonic Saline Solution | Procedure | intra-articular infiltration with Isotonic Saline Solution |
|
| 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 |
| D012216 |
| Rheumatic Diseases |