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PRP Injections for Jumper's Knee (PRP Trial)

Phase 2

Waitlist Available

Led By John J. Wilson, MD, MS

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-65

Chronic (>3 months) patellar tendon pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 4, 8, 12, 16, and 32 weeks

Awards & highlights

PRP Trial Summary

This trial will compare platelet-rich plasma injections to a control group in order to determine if they improve clinical outcomes for chronic patellar tendinopathy. A new ultrasound imaging assessment called Acoustoelastography will be used to help determine the results.

Who is the study for?

This trial is for adults aged 18-65 with chronic patellar tendon pain lasting over 3 months, who haven't improved after physical therapy and at least two common treatments like NSAIDs or bracing. It's not suitable for those using opioids, with bleeding disorders or low platelets, on anticoagulants or immunosuppressives, pregnant women, workers' comp cases, pending litigation participants, or those allergic to acetaminophen/Lidocaine.Check my eligibility

What is being tested?

The study tests if PRP injections are more effective than saline (a placebo) in treating chronic patellar tendinopathy. Participants will be randomly assigned to receive either PRP or saline and followed up for 32 weeks. The effectiveness will be measured through clinical outcomes correlated with a new ultrasound imaging technique called Acoustoelastography.See study design

What are the potential side effects?

Possible side effects of the PRP injection may include pain at the injection site, infection risk increase due to needle use, tissue damage around the knee from incorrect placement of the needle during injection procedure.

PRP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have had knee tendon pain for more than 3 months.

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I have tried at least 2 common treatments for knee tendon pain without success.

Select...

My knee has been diagnosed with patellar tendonitis.

PRP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 4, 8, 12, 16, and 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 4, 8, 12, 16, and 32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 4, 8, 12, 16, and 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in International Knee Documentation Committee (IKDC) Score

Change in Knee Injection Questionnaire Score

Change in Victorian Institute of Sport Assessment-Patellar (VISAP) Score

Secondary outcome measures

Change in Hypoechogenicity of Patellar Tendon

Change in Neovascularity of Patellar Tendon

Change in Stiffness of Patellar Tendon

+1 more

Other outcome measures

Knee

PRP Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Platelet Rich PlasmaActive Control1 Intervention

Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous platelet-rich plasma at week 0 (baseline).

Group II: Group 2Placebo Group1 Intervention

Subjects in Group 2 (saline control) will receive a single injection of 5 mL 0.9% normal saline at week 0.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,182 Previous Clinical Trials

3,167,343 Total Patients Enrolled

John J. Wilson, MD, MSPrincipal InvestigatorUW-Madison School of Medicine & Public Health

1 Previous Clinical Trials

50 Total Patients Enrolled

Stephen J. Almasi, MDPrincipal InvestigatorUW-Madison School of Medicine & Public Health

Media Library

Platelet-Rich Plasma (PRP) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01843504 — Phase 2

Jumper's Knee Research Study Groups: Platelet Rich Plasma, Group 2

Jumper's Knee Clinical Trial 2023: Platelet-Rich Plasma (PRP) Highlights & Side Effects. Trial Name: NCT01843504 — Phase 2

Platelet-Rich Plasma (PRP) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01843504 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How could Platelet Rich Plasma potentially put participants at risk?

"Our research team assigned a score of 2 to Platelet Rich Plasma in terms of safety, as there are data points which indicate its security but no efficacy evidence."

Answered by AI

What are the criteria for joining this experiment?

"This clinical trial is seeking 44 individuals aged 18-65 with a diagnosis of chronic patellar tendinopathy. The selection criteria are as follows: age18-65, prolonged (>3months) tendon pain in the knee; physical examination findings congruent with PT; self-reported unsuccessful treatment through supervised physical therapy and two other common treatments (NSAIDs, relative rest, ice, bracing)."

Answered by AI

Is there an age restriction on the participants of this research?

"According to this trial's enrollment parameters, only individuals aged 18-65 are eligible for participation."

Answered by AI

What goal is the clinical trial attempting to accomplish?

"Over the course of 12 months, this clinical trial will measure its efficacy by analysing changes in International Knee Documentation Committee (IKDC) Score. Secondary outcomes include a comparison of patellar tendon thickness between limbs using ultrasound imaging and an assessment of neovascularity within the tendon through conventional ultrasounds. To analyse stiffness shifts across tendons, acoustoelastography is used with standardised 0-3 severity scales compared to control subjects."

Answered by AI

Are potential participants currently being accepted for this research endeavor?

"Data from clinicaltrials.gov confirms that this research project is not presently searching for patients, despite having been posted on January 1st 2014 and last updated October 6th 2022. However, there are 74 different trials actively recruiting participants at the moment."

Answered by AI

Recent research and studies

Journal of Oral and Maxillofacial SurgeryJournal

Platelet-rich Plasma: Evidence to Support Its Use

Marx, Robert E. 2004. “Platelet-rich Plasma: Evidence to Support Its Use”. Journal of Oral and Maxillofacial Surgery. Elsevier BV. doi:10.1016/j.joms.2003.12.003.

clinicaltrials.govStudy

Platelet-Rich Plasma (PRP) Injection for the Treatment of Chronic Patellar Tendinopathy

2014. "Platelet-Rich Plasma (PRP) Injection for the Treatment of Chronic Patellar Tendinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01843504.

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