Platelet-Rich Plasma vs Hyaluronic Acid for Osteoarthritis

Overseen by Jason L Koh, MD, MBA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Endeavor Health

Must not be taking: Anticoagulants, NSAIDs

Disqualifiers: Autoimmune disorder, Diabetes, Active infections, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a single-center, prospective, randomized, single-blind, comparator therapy, parallel group study for symptomatic patients diagnosed with knee osteoarthritis. The aim is to demonstrate superior efficacy of platelet-rich plasma (PRP) as compared to hyaluronic acid (HA) in treating knee osteoarthritis. This aim will be objectively measured by endpoint consisting of changes in cartilage thickness from baseline in the MRI. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire will be used to calculate The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. It will measure changes in pain and function from baseline. Approximately 100 subjects will be treated at NorthShore University HealthSystem (NorthShore) as part of this study. This study has the potential to improve outcomes in a very common chronic degenerative disease, osteoarthritis, which can have a significant effect on individuals' quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use NSAIDs (non-steroidal anti-inflammatory drugs) 5 days before a blood draw or up to 7 days after the last PRP or HA treatment. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Platelet-Rich Plasma vs Hyaluronic Acid for Osteoarthritis?

Research shows that both platelet-rich plasma (PRP) and hyaluronic acid (HA) are effective for treating knee osteoarthritis, with PRP often providing better pain relief and functional improvement than HA. However, the combination of PRP and HA has shown mixed results, and more studies are needed to confirm its effectiveness. ^{1 2 3 4 5}

Is Platelet-Rich Plasma and Hyaluronic Acid treatment safe for humans?

In studies involving treatments for knee osteoarthritis, the most common side effects reported were high blood pressure and protein in the urine. These treatments are generally considered safe, but like any medical procedure, they can have side effects. ^{4 6 7 8 9}

How does the treatment of platelet-rich plasma (PRP) and hyaluronic acid (HA) differ from other treatments for osteoarthritis?

Platelet-rich plasma (PRP) and hyaluronic acid (HA) are unique non-surgical treatments for osteoarthritis that involve injecting substances directly into the joint to provide relief. PRP uses a patient's own blood to create a concentration of platelets that release growth factors, while HA acts as a lubricant to improve joint movement. These treatments aim to delay the need for surgery and offer an alternative to standard pain relief methods. ^{4 9 10 11 12}

Research Team

Jason L Koh, MD, MBA

Principal Investigator

Clinical Chairman, Dept. of Orthopaedics

Eligibility Criteria

This trial is for adults aged 18-75 with chronic knee pain from osteoarthritis, graded 2-3 on the K-L scale. Participants must have had pain for over three months and score at least a 40 on the VAS for pain. They should be able to consent and pass a physical exam, blood tests including platelet count, CRP, and ESR.

Inclusion Criteria

I have a list of all medications I am currently taking.

Complete Blood Count to include platelets and differential (CBC with Diff) within normal limits

Physical exam and medical history

Exclusion Criteria

Immuno-suppression (e.g., AIDS, etc.)

Platelet counts (PLT) <150,000 /mm3

Pregnancy/Breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either PRP or HA injections for knee osteoarthritis treatment

12 months

Multiple visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person)

Treatment Details

Interventions

• HA Treatment (Viscosupplementation)
• PRP Treatment (Platelet-Rich Plasma)

Trial Overview The study compares two treatments: PRP (platelet-rich plasma) and HA (hyaluronic acid), to see which is better at improving knee osteoarthritis symptoms. It's measured by MRI changes in cartilage thickness and improvements in pain/function via KOOS/WOMAC scores.

Participant Groups

Group I: PRP Treatment Experimental Treatment 1 Intervention

PRP is injected using 22 gauge needles through the classic approach (lateral midpatellar) in a sterile setting. The PRP is obtained from a maximum 16 cc sample of the patients' blood drawn at the time of treatment. Using sterile technique, the venous blood is transferred to a centrifuge and prepared by the centrifugation process for 5 minutes. 4-7 mL of PRP is transferred from the large outer syringe into the small inner syringe and injected within 30 minutes of being spun to negate the need of anticoagulants. The procedure will take approximately 20-30 minutes.

Group II: HA Treatment Active Control 1 Intervention

HA is injected using 22 gauge needles through the classic approach (lateral midpatellar) in a sterile setting. Euflexxa will be prepared according to the package insert.

HA Treatment is already approved in Canada for the following indications:

Approved in Canada as Hyaluronic Acid for:

• Knee osteoarthritis

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

Gerald "J.P." Gallagher

Endeavor Health

Chief Executive Officer since 2022

MBA from Benedictine University

Sanjeeb Khatua, MD

Endeavor Health

Chief Physician Executive since 2023

MD from Rush Medical College

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

David Hall

NorthShore University HealthSystem

Chief Executive Officer since 2009

MBA in Healthcare Management, Western Governors University

Dr. Andi Arnautovic

NorthShore University HealthSystem

Chief Medical Officer since 1989

Residency at Mount Sinai Hospital, Chicago

Findings from Research

In a meta-analysis of 10 studies, intra-articular platelet-rich plasma (PRP) injections were found to be more effective than hyaluronic acid (HA) injections in reducing pain and improving functionality in patients with osteoarthritis, as measured by the IKDC, WOMAC, and VAS scores.

While PRP showed significant benefits over HA in pain relief and functional improvement, both treatments did not differ significantly in the Knee Osteoarthritis Outcome Scores (KOOS), suggesting that while PRP may provide better short-term outcomes, the overall impact on knee function as measured by KOOS may be similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma versus hyaluronic acid in knee osteoarthritis: A meta-analysis with the consistent ratio of injection. Wu, Q., Luo, X., Xiong, Y., et al.[2020]

In a randomized controlled trial involving 111 patients with mild to moderate knee osteoarthritis, platelet-rich plasma (PRP) injections showed significant improvements in subjective knee evaluations compared to hyaluronic acid (HA) at 24 weeks and 52 weeks, despite no difference in the primary pain score measure.

The study suggests that the anti-inflammatory properties of PRP may contribute to symptom improvement, as indicated by trends in reduced proinflammatory cytokines, although the primary outcome measure (WOMAC pain score) did not show a significant difference between PRP and HA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 Cole, BJ., Karas, V., Hussey, K., et al.[2022]

A single intraarticular injection of plasma-rich platelet (PRP) combined with either Artz or HYAJOINT Plus significantly reduced knee pain and improved function in patients with knee osteoarthritis over a 6-month period, with no serious adverse events reported.

While both treatment combinations were effective, the PRP + HYAJOINT Plus group showed superior improvements in specific measures of function and stability, particularly in patients with more severe baseline symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing efficacy of a single intraarticular injection of platelet-rich plasma (PRP) combined with different hyaluronans for knee osteoarthritis: a randomized-controlled clinical trial. Huang, HY., Hsu, CW., Lin, GC., et al.[2023]

In a phase I clinical trial involving 20 patients with mild to moderate knee osteoarthritis, intra-articular injection of platelet-rich plasma (PRP) was found to be safe and resulted in significant and lasting improvements in pain and function over 12 months, outperforming hyaluronic acid (HA) injections.

While both PRP and HA injections alleviated symptoms of knee osteoarthritis, PRP provided greater improvements in patient-reported outcomes and physical examinations, with benefits lasting longer than those seen with HA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Analysis of the Effectiveness of Intra-Articular Injection of Platelet-Rich Plasma versus Hyaluronic Acid for Knee Osteoarthritis: Results of an Open-Label Trial. Jalali Jivan, S., Monzavi, SM., Zargaran, B., et al.[2022]

A systematic review of six studies involving 408 patients found that both platelet-rich plasma (PRP) and hyaluronic acid (HA) injections provide similar short-term clinical benefits for treating hip osteoarthritis, with no significant differences in pain and function scores after treatment.

The analysis included patients with a mean age of around 60 years and a follow-up period of approximately 12 months, indicating that both treatments are effective options for managing symptoms of hip OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Versus Hyaluronic Acid for Hip Osteoarthritis Yields Similarly Beneficial Short-Term Clinical Outcomes: A Systematic Review and Meta-analysis of Level I and II Randomized Controlled Trials. Belk, JW., Houck, DA., Littlefield, CP., et al.[2022]

In a study involving 360 patients with knee osteoarthritis, the combination therapy of platelet-rich plasma (PRP) and hyaluronic acid (HA) significantly improved pain and joint function compared to either treatment alone, indicating a potential new treatment option.

PRP was found to be more effective than HA alone in reducing pain, and the combination therapy also promoted healing processes like angiogenesis, suggesting enhanced cartilage repair mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical therapy of hyaluronic acid combined with platelet-rich plasma for the treatment of knee osteoarthritis. Yu, W., Xu, P., Huang, G., et al.[2020]

Intra-articular treatment with platelet-rich plasma (PRP) showed a significant reduction in pain for patients with hip osteoarthritis at 4 weeks, but this effect did not last by 16 weeks, indicating a short-term benefit.

In contrast, viscosupplementation with hyaluronic acid (HA) demonstrated a sustained reduction in pain from baseline to 16 weeks, suggesting it may be more effective for long-term management of hip osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular hyaluronic acid vs platelet-rich plasma in the treatment of hip osteoarthritis. Di Sante, L., Villani, C., Santilli, V., et al.[2022]

In a meta-analysis of 10 randomized controlled trials involving 1096 overweight or obese patients with knee osteoarthritis, platelet-rich plasma (PRP) injections showed better long-term efficacy than hyaluronic acid (HA) for pain relief and improved function at 3, 6, and 12 months follow-up.

While there was no significant difference between PRP and HA in the first two months, PRP demonstrated significant improvements in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at later time points, indicating its potential as a more effective long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Choose Platelet-Rich Plasma or Hyaluronic Acid for the Treatment of Knee Osteoarthritis in Overweight or Obese Patients: A Meta-Analysis. Luo, P., Xiong, Z., Sun, W., et al.[2020]

Platelet-rich plasma (PRP) injections were found to reduce knee osteoarthritis pain more effectively than hyaluronic acid (HA) at 6 and 12 months, according to the WOMAC pain score, indicating potential efficacy in long-term pain management.

However, the study concluded that PRP was not significantly superior to HA overall, and the authors emphasized the need for more high-quality randomized controlled trials to better understand the effectiveness of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular platelet-rich plasma versus hyaluronic acid in the treatment of knee osteoarthritis: a meta-analysis. Zhang, HF., Wang, CG., Li, H., et al.[2022]

The study involved nine healthy adult volunteers and found that adding hyaluronic acid (HA) to platelet-rich plasma (PRP) significantly increased the release of growth factors like TGF-β1 and PDGF-AA on Day 5, suggesting enhanced therapeutic potential.

The combination of PRP and HA resulted in higher growth factor levels compared to PRP alone, indicating that this mixture may be a more effective treatment option for osteoarthritis and chronic tendinopathy than using either PRP or HA by itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronic acid induces the release of growth factors from platelet-rich plasma. Iio, K., Furukawa, KI., Tsuda, E., et al.[2022]

A meta-analysis of 18 studies involving 1608 patients showed that platelet-rich plasma (PRP) injections resulted in significantly greater improvement in knee osteoarthritis symptoms compared to hyaluronic acid (HA) injections, with a mean improvement of 44.7% for PRP versus 12.6% for HA.

Leukocyte-poor PRP was found to provide better clinical outcomes than leukocyte-rich PRP, suggesting that the type of PRP used may influence treatment effectiveness, although more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Versus Hyaluronic Acid for Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Belk, JW., Kraeutler, MJ., Houck, DA., et al.[2021]

In a meta-analysis of 30 studies involving 2733 patients, platelet-rich plasma (PRP) was found to be more effective than hyaluronic acid (HA) in improving function for patients with osteoarthritis, as measured by the WOMAC and IKDC scores.

Both treatments showed similar safety profiles, with no significant differences in adverse events or pain relief (VAS), and leukocyte-poor PRP (LP-PRP) was more effective than leukocyte-rich PRP (LR-PRP) in functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of clinical efficiency between intra-articular injection of platelet-rich plasma and hyaluronic acid for osteoarthritis: a meta-analysis of randomized controlled trials. Chen, L., Jin, S., Yao, Y., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma versus hyaluronic acid in knee osteoarthritis: A meta-analysis with the consistent ratio of injection. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

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 [2022]

3. England pubmed.ncbi.nlm.nih.gov

Comparing efficacy of a single intraarticular injection of platelet-rich plasma (PRP) combined with different hyaluronans for knee osteoarthritis: a randomized-controlled clinical trial. [2023]

4. Iran pubmed.ncbi.nlm.nih.gov

Comparative Analysis of the Effectiveness of Intra-Articular Injection of Platelet-Rich Plasma versus Hyaluronic Acid for Knee Osteoarthritis: Results of an Open-Label Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Versus Hyaluronic Acid for Hip Osteoarthritis Yields Similarly Beneficial Short-Term Clinical Outcomes: A Systematic Review and Meta-analysis of Level I and II Randomized Controlled Trials. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

Clinical therapy of hyaluronic acid combined with platelet-rich plasma for the treatment of knee osteoarthritis. [2020]

7. Romania pubmed.ncbi.nlm.nih.gov

Intra-articular hyaluronic acid vs platelet-rich plasma in the treatment of hip osteoarthritis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

How to Choose Platelet-Rich Plasma or Hyaluronic Acid for the Treatment of Knee Osteoarthritis in Overweight or Obese Patients: A Meta-Analysis. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Intra-articular platelet-rich plasma versus hyaluronic acid in the treatment of knee osteoarthritis: a meta-analysis. [2022]

10. Singapore pubmed.ncbi.nlm.nih.gov

Hyaluronic acid induces the release of growth factors from platelet-rich plasma. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Versus Hyaluronic Acid for Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Comparison of clinical efficiency between intra-articular injection of platelet-rich plasma and hyaluronic acid for osteoarthritis: a meta-analysis of randomized controlled trials. [2023]