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Trial record 37 of 75 for:    "Collagen Disease" | "Triamcinolone"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03086759
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jose Carlos Nunes Tamashiro, Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: platelet rich plasm Drug: Triamcinolone Hexacetonide Procedure: Isotonic Saline Solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee.
Actual Study Start Date : January 2, 2017
Actual Primary Completion Date : June 2, 2018
Actual Study Completion Date : June 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. Change in pain [ Time Frame: Baseline, after 4, 8, 12 and 48 weeks ]
    Evaluated using a visual analogue scale


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086759


Locations
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Brazil
Universidade Federal de Sao Paulo
Sao Paulo, SP, Brazil, 04023900
Sponsors and Collaborators
Federal University of São Paulo

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Responsible Party: Jose Carlos Nunes Tamashiro, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03086759     History of Changes
Other Study ID Numbers: CEP UNIFESP 842 167/2014
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Pharmaceutical Solutions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action