Status:
COMPLETED
Platelet Rich Plasma Injection for Knee Osteoarthritis
Lead Sponsor:
Ferhat Say
Conditions:
Knee Osteoarthritis
Cartilage Degeneration
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
The research questions of this study are; 1. Is platelet rich plasma (PRP) treatment effective in knee osteoarthritis (OA)? 2. What are the indications for PRP treatment? 3. Which patients are the mo...
Detailed Description
The power analysis of this study was calculated based on the sample size studies of previous studies. The difference of d = 3 units between the two means is to have a standard deviation of 6 units. Th...
Eligibility Criteria
Inclusion
- stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging
- mean VAS pain score of \>4 of 10 (worst possible pain) over the course of 7 days during the previous month
Exclusion
- OA secondary to joint inflammatory diseases,
- generalized OA,
- metabolic diseases of the bone,
- coexisting backache,
- the presence of hematological disease (coagulopathy),
- bilateral symptomatic lesions and advanced stages (grade 4) of OA,
- patients who had received intra-articular injections within 3 months or arthroscopic lavage in the previous 1 year,
- patients who were receiving immunosuppressive,
- patients with current use of anticoagulant medications,
- NSAIDs used in the 5 days before blood donation,
- major axis deviation (more than 15 degree of varus or more than 5 degree of valgus deviation),
- patients with a hemoglobin level less than 11.5 g/dL,
- platelets level less than 100,000/μL,
- associated comorbidities, infection, tumor, crystal arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT04454164
Start Date
June 1 2018
End Date
January 1 2020
Last Update
July 1 2020
Active Locations (1)
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1
Department of Orthopedic and Trauma, Faculty of Medicine, Ondokuz Mayıs University
Samsun, Atakum, Turkey (Türkiye), 55139