Overview

To Evaluate the Optimum Dose of Platelet Rich Plasma in Knee Osteoarthritis and Compare Efficacy With Hyaluronic Acid

Status:
Completed
Trial end date:
2016-07-10
Target enrollment:
0
Participant gender:
All
Summary
Randomized, Double-blind, 12-month, placebo-controlled study was conducted on 100 outpatients . Intervention platelet rich plasma( PRP) prepared from 60 ml of blood by adding novel step of filtration to manual centrifuge step to achieve 7 times concentration. the efficacy was compared with administration of hyaluronic acid. Subjective Womac scores ,6 min pain free walking distance as well objective assessments MRI ,synovial fluid assessments were made out .Absolute counts of platelets as dose was evaluated to be effective in alleviating symptoms in early knee OA.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dr. Himanshu Bansal Foundation
Treatments:
Hyaluronic Acid
Criteria
Inclusion Criteria:

- Outpatients who fulfilled the clinical and radiological criteria set by the American
College of Rheumatology for the diagnosis of symptomatic primary knee OA, with pain
Visual Analogue Scale (VAS) score of >3 in the previous month. In cases where both the
knees were symptomatic, the knee which was comparatively more painful was considered.

Exclusion Criteria:

1. Evidence of secondary knee OA because of injury, inflammatory or metabolic rheumatic
disease, or osteonecrosis;

2. Prior intra-articular injection of hyaluronic acid (HA), including lavage and
corticosteroids within the previous three months;

3. Severe knee OA, with JSW <1 mm, or surgery required on the evaluated knee in the year

4. Patients with clinically significant systemic disease.