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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086759
• Other study ID #: CEP UNIFESP 842 167/2014
• Status: Completed
• Phase: Phase 4
• Start date: January 2, 2017
• Est. completion date: June 2, 2018

Study information

• Verified date: January 2019
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 2, 2018
• Est. primary completion date: June 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• platelet rich plasm
intra-articular infiltration with platelet rich plasm

Drug:
• Triamcinolone Hexacetonide
intra-articular infiltration withTriamcinolone Hexacetonide

Procedure:
• Isotonic Saline Solution
intra-articular infiltration with Isotonic Saline Solution

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	Evaluated using a visual analogue scale	Baseline, after 4, 8, 12 and 48 weeks
Secondary	Change in joint edema	Evaluated using a visual analogue scale	Baseline, after 4, 8, 12 and 48 weeks
Secondary	Change in range of motion	Evaluated using goniometry	Baseline, after 4, 8, 12 and 48 weeks
Secondary	Change in a clinical improvement scale	Evaluated using an improvement scale	Baseline, after 4, 8, 12 and 48 weeks
Secondary	Change in quality of life	Using the SF-36 questionnaire	Baseline, after 4, 8, 12 and 48 weeks
Secondary	Change in functional capacity	Using the WOMAC questionnaire	Baseline, after 4, 8, 12 and 48 weeks
Secondary	Change in functional capacity	Using the M Lequesne questionnaire	Baseline, after 4, 8, 12 and 56 weeks
Secondary	Change in functional capacity	Using the six minute walk test	Baseline, after 4, 8, 12 and 48 weeks
Secondary	Change in functional capacity	Using the time to up and go test	Baseline, after 4, 8, 12 and 48 weeks
Secondary	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