Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
NCT ID: NCT03086759
Last Updated: 2019-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
99 participants
INTERVENTIONAL
2017-01-02
2018-06-02
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Platelet rich plasm group
platelet rich plasm
intra-articular infiltration with platelet rich plasm
Triamcinolone Hexacetonide group
Triamcinolone Hexacetonide
intra-articular infiltration withTriamcinolone Hexacetonide
Isotonic Saline Solution group
Isotonic Saline Solution
intra-articular infiltration with Isotonic Saline Solution
Interventions
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platelet rich plasm
intra-articular infiltration with platelet rich plasm
Triamcinolone Hexacetonide
intra-articular infiltration withTriamcinolone Hexacetonide
Isotonic Saline Solution
intra-articular infiltration with Isotonic Saline Solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Jose Carlos Nunes Tamashiro
Principal Investigator
Locations
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Universidade Federal de Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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CEP UNIFESP 842 167/2014
Identifier Type: -
Identifier Source: org_study_id
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