PRP Injections for Knee Osteoarthritis

(PRP Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Oral steroids

Disqualifiers: Recent knee surgery, BMI over 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, lower-cost method of using platelet-rich plasma (PRP) injections to treat knee osteoarthritis. PRP, derived from a patient's own blood, might reduce pain and improve knee function more effectively than standard treatments like cortisone shots. The trial aims to make PRP more affordable and enhance its study. It suits adults who have experienced knee osteoarthritis pain for at least six weeks and haven't found relief with regular treatments like medication or physical therapy. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to more accessible treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot have taken oral steroids in the last three months.

What prior data suggests that this PRP injection is safe for knee osteoarthritis?

Research has shown that platelet-rich plasma (PRP) injections are generally safe for treating knee osteoarthritis. In studies, most patients reported satisfaction with PRP treatments, with 90% satisfied after six months and 75% after twelve months. Importantly, no major unwanted side effects occurred. PRP injections are considered safer than the more common corticosteroid injections, which can cause side effects like changes in blood sugar and blood pressure. Overall, PRP is well-tolerated and could be a promising option for those dealing with knee pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LC-PRP injections for knee osteoarthritis because this treatment aims to significantly reduce costs while ensuring effective care. Unlike traditional platelet-rich plasma (PRP) treatments, which can be expensive due to commercial kit costs, LC-PRP uses a low-cost preparation technique that makes it more accessible to a broader range of patients. By addressing socioeconomic barriers, LC-PRP has the potential to provide relief to those who might otherwise be unable to afford current PRP options, without compromising the quality of care.

What evidence suggests that LC-PRP is effective for knee osteoarthritis?

Research has shown that Platelet-Rich Plasma (PRP) injections can help with knee osteoarthritis (OA). Reviews have found that PRP often works as well as, or even better than, placebo treatments, hyaluronic acid, and traditional steroid treatments for knee OA. PRP typically has fewer side effects than steroid injections, making it a safer choice for most people. This trial will specifically evaluate low-cost PRP (LC-PRP), which studies suggest is both effective and affordable, offering significant benefits to patients. Although some concerns about study bias and costs exist, ongoing research aims to address these issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Daniel Cushman, MD

Principal Investigator

University of Utah Orthopedic Center

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis, seeking alternative treatments to corticosteroids. It's likely more suitable for those who have concerns about the side effects of standard injections or are interested in newer therapeutic options.

Inclusion Criteria

I have knee pain due to arthritis, confirmed by recent X-rays.

I have tried standard treatments like medication or physical therapy for over six weeks without success.

Both of my knees meet the study's requirements for osteoarthritis.

Exclusion Criteria

I had knee surgery within the last two years.

I have a significant spinal curve over 30 degrees.

I have not had an injection in the affected joint in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-cost PRP injections for knee osteoarthritis

6 months

Injections at baseline, 1 month, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Follow-up assessments at 1, 3, 6, and 12 months after the second injection

What Are the Treatments Tested in This Trial?

Interventions

• LC-PRP

Trial Overview

The study tests a low-cost Platelet-Rich Plasma (LC-PRP) injection directly into the knee joint as a treatment for pain and functional impairment caused by osteoarthritis, comparing its effectiveness and safety against traditional therapies.

How Is the Trial Designed?

Group I: Directly Address Two Concerns - Proper Reporting of PRP Composition and Greatly Decreasing Cost Experimental Treatment 1 Intervention

As socioeconomic inequity directly relates to disability related to knee Osteoarthritis (OA), limiting the cost of treatment is of the utmost importance to ensure appropriate delivery of care to all patients. As PRP is currently not covered by the vast majority of public and private payors, patients are required to pay for the injections out of pocket, with an average cost of $714 per injection (as high as $2,092). Furthermore, research studies relating to PRP are often expensive due to the cost of the traditional method of extracting PRP, generally with commercial kits, and thus limited in scope. The investigators have developed and implemented a low-cost PRP (LC-PRP) preparation technique and have safely performed the injections on hundreds of patients with knee OA.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

In a study of nine women with knee osteoarthritis, intra-articular injections of leukocyte-poor platelet-rich plasma (LP-PRP) led to significant improvements in functional knee scores over a three-year follow-up, particularly in gait and stair navigation.

Most patients (six out of eight) did not require additional treatment, and while some radiological progression was noted, the overall safety and feasibility of LP-PRP injections were confirmed, with no worsening of osteoarthritis in the majority of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-Articular Leukocyte-Poor Platelet-Rich Plasma Injections for Japanese Patients With Osteoarthritis of the Knee: A Three-Year Observational Retrospective Study After Phase 1 and Phase 2a Trials. Taniguchi, Y., Yoshioka, T., Sugaya, H., et al.[2022]

Intra-articular platelet-rich plasma (PRP) injections significantly relieve pain in knee osteoarthritis compared to saline and corticosteroid injections, with a large effect size indicating clinical importance.

There was no significant difference in effectiveness between leukocyte-poor PRP (LP-PRP) and leukocyte-rich PRP (LR-PRP), suggesting both types may be similarly beneficial, but further high-quality studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Clinical Trials. Nie, LY., Zhao, K., Ruan, J., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12411927/

An evaluation of a low‐cost platelet‐rich plasma for ...

This pilot study demonstrates that LC‐PRP ($11) may significantly benefit patients with knee OA. LC‐PRP appears to be a safe, cost‐effective ...

2.

esskajournals.onlinelibrary.wiley.com

esskajournals.onlinelibrary.wiley.com/doi/abs/10.1002/jeo2.70420

An evaluation of a low‐cost platelet‐rich plasma for ...

This pilot study demonstrates that LC-PRP ($11) may significantly benefit patients with knee OA. LC-PRP appears to be a safe, cost-effective ...

3.

journaloei.scholasticahq.com

journaloei.scholasticahq.com/article/117195-platelet-rich-plasma-injection-in-knee-osteoarthritis-results-after-four-years

Platelet rich plasma injection in knee osteoarthritis: results ...

According to data on file from the manufacturer, this system provides 90% of recovery of platelets and concentrates platelets to 9.3 times over ...

4.

frontiersin.org

frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2022.1062371/full

Assessment of the effectiveness and satisfaction of platelet ...

Results: With surgery for any reason as the endpoint, the cumulative survival rate of the PRP group was 90%, while that of the HA group was 74%. There was a ...

5.

bmcmusculoskeletdisord.biomedcentral.com

bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-021-04706-7

a double-blinded placebo-controlled randomized clinical trial

PRP and plasma were not superior to placebo for pain and function improvement in KOA over 24 weeks. The PRP group had a higher frequency of mild transitory ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12535052/

Efficacy and safety of platelet-rich plasma injections for the ...

Animal studies have further confirmed that intra-articular PRP injection can reduce inflammation levels, alleviate cartilage damage, and ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S235232042500032X

Optimal frequency of platelet-rich plasma injections for ...

Optimal results achieved with 4–5 PRP injections, depending on disease severity. PRP therapy shows sustained improvements in pain relief and functional ...

8.

orthopedicreviews.openmedicalpublishing.org

orthopedicreviews.openmedicalpublishing.org/article/94236-a-comparison-of-intra-articular-hyaluronic-acid-and-platelet-rich-plasma-for-knee-osteoarthritis-a-systematic-review

a comparison of intra-articular hyaluronic acid and platelet ...

For long-term usage, PRP seems to be superior to HA. However there is insufficient data for objective outcome improvement for PRP uses in KOA.