Clinical trial NCT03086759: Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
Official title: Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 99
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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
* 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

Primary outcomes:
measure: Change in pain
timeFrame: Baseline, after 4, 8, 12 and 48 weeks
Secondary outcomes:
measure: Change in joint edema
timeFrame: Baseline, after 4, 8, 12 and 48 weeks
measure: Change in range of motion
timeFrame: Baseline, after 4, 8, 12 and 48 weeks
measure: Change in a clinical improvement scale
timeFrame: Baseline, after 4, 8, 12 and 48 weeks
measure: Change in quality of life
timeFrame: Baseline, after 4, 8, 12 and 48 weeks
measure: Change in functional capacity
timeFrame: Baseline, after 4, 8, 12 and 48 weeks
measure: Change in functional capacity
timeFrame: Baseline, after 4, 8, 12 and 56 weeks
measure: Change in functional capacity
timeFrame: Baseline, after 4, 8, 12 and 48 weeks
measure: Change in functional capacity
timeFrame: Baseline, after 4, 8, 12 and 48 weeks
measure: Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler
timeFrame: Baseline, after 4, 8, 12 and 48 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP
Study officials:
References: