Intratendinous Injections of Platelet Rich Plasma With or Without Leukocyte Enrichment for Patellar Tendinopathy: a Randomized Controlled Trial

University of British Columbia5 sites in 4 countries64 target enrollmentMarch 2014

ConditionsPatellar Tendinopathy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Patellar Tendinopathy
Sponsor: University of British Columbia
Enrollment: 64
Locations: 5
Primary Endpoint: Clinical Efficacy
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized controlled clinical trial to investigate the effectiveness, safety and tolerability of platelet-rich plasma (PRP) injections for treatment of patellar tendinopathy in adults 18-50 years of age. Subjects will be randomly assigned to three parallel treatment groups:

Leukocyte-rich PRP injection + exercise
Leukocyte-poor PRP injection + exercise
Saline injection + exercise (control) Primary endpoints are (1) the number (rate) and severity of adverse events as reported by both patients and study physicians during the first 12 weeks after initiation of treatment, (2) patient-rated tolerability of treatment; (3) the change in function (VISA score) and treatment success (global improvement scale) over six months of a post-injection exercise protocol.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

December 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of British Columbia

Responsible Party

Principal Investigator

Alexander Scott

Principal Investigator

University of British Columbia

Eligibility Criteria

Inclusion Criteria

•Male or female ≥ 18 and ≤ 50 years of age at Enrollment Visit
•Documentation of a clinical diagnosis of patellar tendinopathy, grade-IIIB Blazina stage, confirmed on ultrasound
•Previously tried an exercise program of at least six weeks duration
•Fluent in official language of study site
•Written informed consent obtained from subject
•Normal values on screening laboratory panels (CBC, PT, PTT, INR, serum creatine, ALT, ALP, AST, bilirubin, albumin)

Exclusion Criteria

•For women of child-bearing potential, positive pregnancy test at enrollment visit
•Major surgery in the past three months
•Surgery on the symptomatic knee
•Bleeding disorder
•Systemic inflammatory disease
•Arthritis or degenerative knee condition
•Recent fluoroquinolone use
•Subjects who have any requirement for the use of systemic steroids or immunosuppressants
•Subjects who are known to be HIV positive
•Uncooperative patient, or patients who are incapable of following directions or who are predictably unwilling to return for follow-up examinations

Outcomes

Primary Outcomes

Clinical Efficacy

Time Frame: 2 years

Number and frequency of adverse events will be assessed/reported weekly for the first 12 weeks and at the 6 month visit.

Secondary Outcomes

Change in function over time measured by VISA Score(2 years)
Comparison of treatment success measured by Likert Global Improvement Scale(2 years)
Change in activity levels over time measured by Tegner Activity Score(2 years)
Change in activity-related pain over time measured by Pain Numeric Rating Scale(2 years)