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

NCT03086759 | Completed Phase 4

• 1 other identifier: CEP UNIFESP 842 167/2014
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in pain

  Evaluated using a visual analogue scale

  Baseline, after 4, 8, 12 and 48 weeks

Secondary Outcomes (9)

• Change in joint edema

  Baseline, after 4, 8, 12 and 48 weeks

• Change in range of motion

  Baseline, after 4, 8, 12 and 48 weeks

• Change in a clinical improvement scale

  Baseline, after 4, 8, 12 and 48 weeks

• Change in quality of life

  Baseline, after 4, 8, 12 and 48 weeks

• Change in functional capacity

  Baseline, after 4, 8, 12 and 48 weeks

Study Arms (3)

Platelet rich plasm group

EXPERIMENTAL

Procedure: platelet rich plasm

Triamcinolone Hexacetonide group

ACTIVE COMPARATOR

Drug: Triamcinolone Hexacetonide

Isotonic Saline Solution group

PLACEBO COMPARATOR

Procedure: Isotonic Saline Solution

Interventions

platelet rich plasm PROCEDURE

intra-articular infiltration with platelet rich plasm

Platelet rich plasm group

Triamcinolone Hexacetonide DRUG

intra-articular infiltration withTriamcinolone Hexacetonide

Triamcinolone Hexacetonide group

Isotonic Saline Solution PROCEDURE

intra-articular infiltration with Isotonic Saline Solution

Isotonic Saline Solution group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023900, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

triamcinolone hexacetonide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: January 2, 2017
• Primary Completion: June 2, 2018
• Study Completion: June 2, 2018
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

BR (1)