Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
platelet rich plasm
Triamcinolone Hexacetonide
Isotonic Saline Solution
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility 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
Sites / Locations
- Universidade Federal de Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Platelet rich plasm group
Triamcinolone Hexacetonide group
Isotonic Saline Solution group
Arm Description
Outcomes
Primary Outcome Measures
Change in pain
Evaluated using a visual analogue scale
Secondary Outcome Measures
Change in joint edema
Evaluated using a visual analogue scale
Change in range of motion
Evaluated using goniometry
Change in a clinical improvement scale
Evaluated using an improvement scale
Change in quality of life
Using the SF-36 questionnaire
Change in functional capacity
Using the WOMAC questionnaire
Change in functional capacity
Using the M Lequesne questionnaire
Change in functional capacity
Using the six minute walk test
Change in functional capacity
Using the time to up and go test
Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler
Using an ultrasound exam
Full Information
NCT ID
NCT03086759
First Posted
March 16, 2017
Last Updated
January 16, 2019
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03086759
Brief Title
Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
Official Title
Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
June 2, 2018 (Actual)
Study Completion Date
June 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet rich plasm group
Arm Type
Experimental
Arm Title
Triamcinolone Hexacetonide group
Arm Type
Active Comparator
Arm Title
Isotonic Saline Solution group
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
platelet rich plasm
Intervention Description
intra-articular infiltration with platelet rich plasm
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Hexacetonide
Intervention Description
intra-articular infiltration withTriamcinolone Hexacetonide
Intervention Type
Procedure
Intervention Name(s)
Isotonic Saline Solution
Intervention Description
intra-articular infiltration with Isotonic Saline Solution
Primary Outcome Measure Information:
Title
Change in pain
Description
Evaluated using a visual analogue scale
Time Frame
Baseline, after 4, 8, 12 and 48 weeks
Secondary Outcome Measure Information:
Title
Change in joint edema
Description
Evaluated using a visual analogue scale
Time Frame
Baseline, after 4, 8, 12 and 48 weeks
Title
Change in range of motion
Description
Evaluated using goniometry
Time Frame
Baseline, after 4, 8, 12 and 48 weeks
Title
Change in a clinical improvement scale
Description
Evaluated using an improvement scale
Time Frame
Baseline, after 4, 8, 12 and 48 weeks
Title
Change in quality of life
Description
Using the SF-36 questionnaire
Time Frame
Baseline, after 4, 8, 12 and 48 weeks
Title
Change in functional capacity
Description
Using the WOMAC questionnaire
Time Frame
Baseline, after 4, 8, 12 and 48 weeks
Title
Change in functional capacity
Description
Using the M Lequesne questionnaire
Time Frame
Baseline, after 4, 8, 12 and 56 weeks
Title
Change in functional capacity
Description
Using the six minute walk test
Time Frame
Baseline, after 4, 8, 12 and 48 weeks
Title
Change in functional capacity
Description
Using the time to up and go test
Time Frame
Baseline, after 4, 8, 12 and 48 weeks
Title
Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler
Description
Using an ultrasound exam
Time Frame
Baseline, after 4, 8, 12 and 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
We'll reach out to this number within 24 hrs