Skip to main content
OpenTrials
Completed

NCT Number: NCT03086759

Intra-Articular Platelet Rich Plasm Use 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universidade Federal de Sao Paulo

São Paulo, 04023900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

platelet rich plasm

Procedure

intra-articular infiltration with platelet rich plasm

Triamcinolone hexacetonide

Drug

intra-articular infiltration withTriamcinolone Hexacetonide

Isotonic Saline Solution

Procedure

intra-articular infiltration with Isotonic Saline Solution

Primary outcomes

  1. Change in pain

    Time frame: Baseline, after 4, 8, 12 and 48 weeks

    Evaluated using a visual analogue scale

Secondary outcomes

  1. Change in joint edema

    Time frame: Baseline, after 4, 8, 12 and 48 weeks

    Evaluated using a visual analogue scale

  2. Change in range of motion

    Time frame: Baseline, after 4, 8, 12 and 48 weeks

    Evaluated using goniometry

  3. Change in a clinical improvement scale

    Time frame: Baseline, after 4, 8, 12 and 48 weeks

    Evaluated using an improvement scale

  4. Change in quality of life

    Time frame: Baseline, after 4, 8, 12 and 48 weeks

    Using the SF-36 questionnaire

  5. Change in functional capacity

    Time frame: Baseline, after 4, 8, 12 and 48 weeks

    Using the WOMAC questionnaire

  6. Change in functional capacity

    Time frame: Baseline, after 4, 8, 12 and 56 weeks

    Using the M Lequesne questionnaire

  7. Change in functional capacity

    Time frame: Baseline, after 4, 8, 12 and 48 weeks

    Using the six minute walk test

  8. Change in functional capacity

    Time frame: Baseline, after 4, 8, 12 and 48 weeks

    Using the time to up and go test

  9. Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler

    Time frame: Baseline, after 4, 8, 12 and 48 weeks

    Using an ultrasound exam

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2017
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.