Platelet Rich Plasma Injection for Knee Osteoarthritis

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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 most suitable for the PRP treatment method?

4. How does age, Body Mass Index (BMI), lower extremity mechanical axis angle and OA stages affect the success of the PRP treatment?

5. Is there any advantage of multiple PRP doses?

6. What is the therapeutic effect of placebo?

This study was designed to find answers of these questions.

The hypotheses of this study are; "PRP treatment is more effective than placebo; PRP treatment effectiveness decreases with age and advanced stages of OA; BMI is a factor that negatively affects the treatment effectiveness of the PRP; as the mechanical axis angle of the lower limb increases, it will adversely affect the effectiveness of PRP therapy; multiple dose of PRP affects the effectiveness and duration of PRP as positively compared to single dose of PRP".

The primary purpose of this study; to prove the effectiveness of PRP treatment on knee pain and functions in patients with knee OA by comparing it with the placebo control group. Secondary purposes of this study; to understand the effect of age, BMI, OA grade and lower limb mechanical axis angle on PRP effectiveness. This study, designed as a randomized, double-blind and placebo control group, with a high level of scientific evidence. Thus, it will be scientifically possible to find answers to the investigators research questions and to prove the investigators hypothesis.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferhat Say

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.