Expired Study
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Chicago, Illinois 60612


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

10012103-AM02


NCT ID:

NCT02588872


Secondary ID:


Study Acronym:

HA vs PRP


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Rush University Medical Center


Oversight Authority:

United States: Institutional Review Board (FWA00000482)


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

111


Enrollment Type:

Actual


Study Dates

Start Date:August 2011
Completion Date:April 2015
Completion Type:Actual
Primary Completion Date:April 2015
Primary Completion Type:Actual
Verification Date:October 2015
Last Changed Date:October 27, 2015
First Received Date:October 25, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Biologic Testing of Synovial Fluid Via ELISA Assays
Time Frame:Primary outcome will be change from pre-treatment to 6-month post treatment.
Safety Issues:False
Description:ELISA analysis will be performed for the following biological markers: IL-1β, IL-1ra, IL-6, IL-8, TNFα
Outcome Type:Secondary Outcome
Measure:Lysholm Knee Score
Time Frame:This will be assessed as a change from pre-treatment visit to 1 year post treatment. 6-weeks post-tr
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Western Ontario and McMaster Universities Arthritis Index
Time Frame:This will be assessed as a change from pre-treatment visit to 1 year post treatment. 6-weeks post-tr
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Visual Analogue Scale (VAS)
Time Frame:This will be assessed as a change from pre-treatment visit to 1 year post treatment. 6-weeks post-tr
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:International Knee Documentation Committee Score (IKDC
Time Frame:This will be assessed as a change from pre-treatment visit to 1 year post treatment. 6-weeks post-tr
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Biological
Name:Platelet-rich Plasma (PRP)
Arm Name:Platelet-rich Plasma (PRP)
Intervention Type:Biological
Name:Hyaluronic Acid
Arm Name:Hyaluronic Acid (HA)

Study Arms

Study Arm Type:Experimental
Arm Name:Platelet-rich Plasma (PRP)
Description:Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.
Study Arm Type:Active Comparator
Arm Name:Hyaluronic Acid (HA)
Description:Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Rush University Medical Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:Cornell University College of Veterinary Medicine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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