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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment LC-PRP for knee osteoarthritis?

Research suggests that platelet-rich plasma (PRP) injections can be effective for knee osteoarthritis, with some studies indicating that leukocyte-poor PRP (LP-PRP) might be more suitable than leukocyte-rich PRP (LR-PRP) for this condition. ^{1 2 3 4 5}

Is PRP safe for treating knee osteoarthritis?

Studies have shown that PRP injections, including those from umbilical cord blood, are generally safe for treating knee osteoarthritis, with no serious adverse events reported in the research. ^{1 6 7 8 9}

How is the PRP treatment for knee osteoarthritis different from other treatments?

PRP (platelet-rich plasma) treatment for knee osteoarthritis is unique because it uses components from your own blood to promote healing in the knee joint. Unlike other treatments, PRP specifically targets not just the cartilage but also the surrounding tissues, potentially delaying the progression of osteoarthritis. ^{1 3 4 8 10}

What is the purpose of this trial?

Knee osteoarthritis is an extremely common and debilitating condition, more common in women, with an estimated global prevalence of 16%, and as high as 50% by the age of 80. Current management of knee osteoarthritis (OA) revolves around conservative treatments- biomechanical interventions, intra-articular injections, exercise, self-management and education, oral or topical medications, strength training, and weight management - or surgical management. For injection therapies, corticosteroids remain the standard of care; approximately 84% of sports medicine physicians perform these knee injections at least monthly, reporting a median range of 11-20 injections per month. Multiple detrimental effects of corticosteroid injections are well-known, including alterations of the hypothalamic-pituitary-adrenal axis, blood glucose levels, bone turnover, inflammatory response, blood pressure, and psychologic well-being. Thus, alternative therapies are of the utmost importance. Platelet-Rich Plasma (PRP) is an injectable preparation of a patient's blood that can be used for numerous conditions and has received significant attention over the past several years for its potential application for the treatment of pain and functional impairment due to knee OA. Systematic reviews of randomized-controlled trials have demonstrated equivalent-to-superior treatment outcomes associated with the use of intra-articular PRP compared to placebo, hyaluronic acid, and corticosteroid. Furthermore, use of intra-articular PRP is associated with a very low rate of adverse events and is likely safer than injectable corticosteroids. Concerns that have limited a wider use of PRP include two main concerns - an uncertainty regarding the current evidence base due to study-related bias, heterogeneity, and lack of reporting standards; and second, more importantly, the main issue remains high cost.

Research Team

Daniel Cushman, MD

Principal Investigator

University of Utah Orthopedic Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Effectiveness of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Clinical Trials. [2022]

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

Short-term clinical results of intra-articular PRP injections for early osteoarthritis of the knee. [2018]

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

Clinical outcome and risk factor predictive for failure of autologous PRP injections for low-to-moderate knee osteoarthritis. [2021]

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

Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of Responders and Impaired Patients with Knee Osteoarthritis Treated with Two Consecutive Injections of Very Pure Platelet-Rich Plasma (PRP). [2023]

6. United States 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. [2022]

7. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Allogenic platelet concentrates from umbilical cord blood for knee osteoarthritis: preliminary results. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Single Injection of High Volume of Autologous Pure PRP Provides a Significant Improvement in Knee Osteoarthritis: A Prospective Routine Care Study. [2020]

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

Growth Factors Levels Determine Efficacy of Platelets Rich Plasma Injection in Knee Osteoarthritis: A Randomized Double Blind Noninferiority Trial Compared With Viscosupplementation. [2022]

10. Scotland pubmed.ncbi.nlm.nih.gov

A systematic review of the effects of platelet rich plasma on outcomes for patients with knee osteoarthritis and following total knee arthroplasty. [2018]