Hyaluronic Acid vs Platelet Rich Plasma: Effects on Clinical Outcomes and Intra-articular Biology for the Treatment of Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

— HA vs PRP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588872
• Other study ID #: 10012103-AM02
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: April 2015

Study information

• Verified date: March 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The objective of this double-blind prospective randomized clinical trial is to compare the effects of PRP to HA in patients with mild to moderate OA using biologic and clinical correlates of outcomes associated with the treatment of OA. The investigators will test the null hypothesis that there are no differences in clinical outcomes as measured by validated clinical scoring systems for OA, nor is there any difference in intra-articular biology between groups of patients treated with HA and those treated with PRP over time.

This study was a prospective, randomized, double blind, comparative clinical trial with an allocation ratio of 1:1 that underwent IRB approval at the principal institution. Between 2011 and 2014 patients will be screened for participation. All comers with a diagnosis of osteoarthritis of the knee between 18 and 80 years of age will be screened.

Treatment and Evaluation Patients who meet inclusion criteria will be randomized via an electronic randomization process into two groups: one receiving intra-articular PRP and the other, intra-articular HA. Non-clinical staff will perform randomization, clinical staff performed the injections, and results and analyses will be performed by the primary research team. Patients and the primary research team performing analysis will be blinded to assignments. All patients will undergo a 10 ml blood draw for PRP preparation and a 3 ml peripheral blood draw for a complete blood count with leukocyte differential. This will be performed on patients who received HA to maintain patient blinding and to characterize the peripheral white blood cells (WBC) and platelet counts. A complete blood count (CBC) will be completed on PRP prior to injection to evaluate the fold increase in platelet concentration and to confirm rarity of red white blood cells. A synovial fluid aspirate of approximately 2cc will be performed under ultrasound guidance just prior to each PRP or HA injection for ELISA analysis of basal and post-treatment intra-articular environment. After treatment, patients will be instructed to limit the use of the leg for at least 24 hours and use cold therapy/icing for discomfort. During this treatment period rest or mild exertion activities (such as exercise bike, aquatic therapy) are recommended, followed by gradual return to sports or recreational activities as tolerated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Platelet-rich Plasma (PRP)

• Hyaluronic Acid

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Knee Documentation Committee Score (IKDC	This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.	This will be assessed as a change from pre-treatment visit to 1 year post treatment.
Secondary	Visual Analogue Scale (VAS)	This is a scale from 1-100, 100 being the worst pain imaginable and 1 being no pain at all that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.	This will be assessed as a change from pre-treatment visit to 1 year post treatment.
Secondary	Western Ontario and McMaster Universities Arthritis Index	This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.	This will be assessed as a change from pre-treatment visit to 1 year post treatment. 6-weeks post-treatment, 6-months post treatment, and finally at 1-year post treatment will be documented for the purpose of trending data.
Secondary	Lysholm Knee Score	This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.	This will be assessed as a change from pre-treatment visit to 1 year post treatment.
Secondary	Biologic Testing of Synovial Fluid Via ELISA Assays	ELISA analysis will be performed for the following biological markers: IL-1ß, IL-1ra, IL-6, IL-8, TNFa	Primary outcome will be change from pre-treatment to 6-month post treatment.