Biological
PRP for Patellar Tendinitis
University of Wisconsin, Madison, Madison, WI
PRP +2 morePhase 2Waitlist AvailableLed by Kenneth Lee, MDResearch Sponsored by University of Wisconsin, MadisonEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing).
Age between 18 and 39 years
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up52 weeks
Awards & highlights
Study Summary
This trial is investigating whether or not platelet-rich plasma is an effective treatment for patellar tendinopathy. Double-blinded means that neither the participants nor the researchers will know who is receiving the treatment until after the study is completed.
Eligible Conditions
- Patellar Tendinitis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
The person has failed at least 2 of the most common treatments for PT, such as NSAIDs, relative rest, ice, and bracing.
Select...
The text states that the age range between 18 and 39 years is when people are considered to be the most productive.
Select...
The pain score is 3 or more on a 10 point scale.
Select...
does not always equate to loss of muscle bulk
Not all supervised physical therapy leads to the loss of muscle bulk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure of activity level
Measure of pain level
Secondary outcome measures
Isokinetic Dynamometer measure of flexor and extensor muscle strength before and after the intervention
MRI Scan To demonstrate treatment-related changes in pathologic imaging features of PT (thickness and T2 signal intensity).
Ultrasound Scan to demonstrate treatment-related changes in pathologic imaging features of PT (thickness, echogenicity, and hyperemia)
Other outcome measures
Relationship between changes in novel quantitative MRI and US parameters of PT and clinical and biomechanical improvement following treatment.
Side effects data
From 2020 Phase 4 trial • 70 Patients • NCT0298422826%
Weakness of muscle surrounding injection site
12%
Difficulty moving affected shoulder joint
3%
Allergic reaction with itchiness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Platelet-rich Plasma (PRP)
Hyaluronic Acid
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Platelet-Rich Plasma (PRP)Experimental Treatment1 Intervention
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
Group II: Dry Needling ProcedurePlacebo Group1 Intervention
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Group III: Sham ProcedurePlacebo Group1 Intervention
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRP
2014
Completed Phase 4
~1840
Find a site
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,118 Previous Clinical Trials
2,936,455 Total Patients Enrolled
General ElectricIndustry Sponsor
45 Previous Clinical Trials
12,359 Total Patients Enrolled
Kenneth Lee, MDPrincipal Investigator
University of Wisconsin, Madison1 Previous Clinical Trials
20 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any restrictions regarding who can enroll in this research project?
"This trial is only open to those between 18 and 39 years old who have tendinitis. A total of 30 patients are needed for this clinical study."
Answered by AI
What is the maximum risk that somebody faces when using PRP?
"PRP has undergone some testing for safety, as is common in Phase 2 trials. However, there is no data currently available supporting its efficacy."
Answered by AI
Are there any patients that you are currently enrolling for this experiment?
"This particular clinical trial, which was originally announced on April 25th, 2017, is still recruiting patients according to the latest update on July 12th, 2022."
Answered by AI
Will this research be testing elderly patients over the age of seventy?
"The age limit for this clinical trial is 18 years or older and 39 years or younger."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
University of Wisconsin, Madison
What portion of applicants met pre-screening criteria?
Met criteria