Clinical trial

Hyaluronic Acid vs Platelet Rich Plasma: Prospective Double-blind Randomized Controlled Trial Comparing Clinical Outcomes and the Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis

Name
10012103-AM02
Description
In this, prospective, double-blind study, patients with mild to moderate symptomatic knee osteoarthritis will be randomized to receive either a series of leukocyte poor, platelet-rich plasma or hyaluronic acid injections under ultrasound guidance. Clinical data in the form of subjective outcome measures will be collected pre-treatment and at four time intervals across a 1-year period. Synovial fluid will also collected for analysis of pro- and anti-inflammatory markers pre-treatment, and at 12 and 24 weeks.
Trial arms
Trial start
2011-08-01
Estimated PCD
2015-04-01
Trial end
2015-04-01
Status
Completed
Treatment
Platelet-rich Plasma (PRP)
Arms:
Platelet-rich Plasma (PRP)
Hyaluronic Acid
Arms:
Hyaluronic Acid (HA)
Size
111
Primary endpoint
International Knee Documentation Committee Score (IKDC
This will be assessed as a change from pre-treatment visit to 1 year post treatment.
Eligibility criteria
Inclusion Criteria: * 18-80 years old * Mild to moderate unilateral, symptomatic osteoarthritis of the knee * No recent (within 3 months) intra-articular intervention to the affected knee Exclusion Criteria: * Knee instability * Varus/Valgus alignment \>5 degrees * Bilateral knee osteoarthritis * Systemic inflammatory arthropathy * Known history of anemia, coagulopathy, or present use of blood thinners
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 111, 'type': 'ACTUAL'}}
Updated at
2023-03-14

1 organization

2 products

2 indications

Indication
Osteoarthritis
Indication
Knee