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

Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee.

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: platelet rich plasm; Drug: Triamcinolone Hexacetonide; Procedure: Isotonic Saline Solution

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04023900
      • Universidade Federal de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Evaluated using a visual analogue scale	Baseline, after 4, 8, 12 and 48 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2017
• Primary Completion (ACTUAL): June 2, 2018
• Study Completion (ACTUAL): June 2, 2018

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (ACTUAL): March 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: CEP UNIFESP 842 167/2014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No