Hyaluronic Acid vs Platelet Rich Plasma: Effects on Clinical Outcomes and Intra-articular Biology for the Treatment of Knee Osteoarthritis
HA vs PRP
1 other identifier
interventional
111
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 25, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedResults Posted
Study results publicly available
May 18, 2017
CompletedMarch 14, 2023
March 1, 2023
3.7 years
October 25, 2015
April 12, 2017
March 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Visual Analogue Scale (VAS)
This will be assessed as a change from pre-treatment visit to 1 year post treatment.
Western Ontario and McMaster Universities Arthritis Index
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.
Lysholm Knee Score
This will be assessed as a change from pre-treatment visit to 1 year post treatment.
Biologic Testing of Synovial Fluid Via ELISA Assays
Primary outcome will be change from pre-treatment to 6-month post treatment.
Study Arms (2)
Hyaluronic Acid (HA)
ACTIVE COMPARATORHyaluronic 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.
Platelet-rich Plasma (PRP)
EXPERIMENTALPlatelet-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.
Interventions
Eligibility Criteria
You may qualify if:
- years old
- Mild to moderate unilateral, symptomatic osteoarthritis of the knee
- No recent (within 3 months) intra-articular intervention to the affected knee
You may not qualify if:
- Knee instability
- Varus/Valgus alignment \>5 degrees
- Bilateral knee osteoarthritis
- Systemic inflammatory arthropathy
- Known history of anemia, coagulopathy, or present use of blood thinners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- Cornell Universitycollaborator
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Related Publications (1)
Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21.
PMID: 28146403DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mukesh Ahuja
- Organization
- Rush University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Trials Investigator, Rush University Medical Center
Study Record Dates
First Submitted
October 25, 2015
First Posted
October 28, 2015
Study Start
August 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
March 14, 2023
Results First Posted
May 18, 2017
Record last verified: 2023-03