Plasma Injections Plus Exercise for Patellar Tendinopathy

Stopped early · Phase 2

Conditions studied: Patellar Tendinopathy

In brief

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: 1. Leukocyte-rich PRP injection + exercise 2. Leukocyte-poor PRP injection + exercise 3. 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.

Key facts

Study ID

NCT02116946

Run by

University of British Columbia

People needed

64

Starts

2014-03-01

Expected to finish

2018-12-01

Last updated by the study team

2018-12-21

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Where it is running

• The Steadman Clinic — Vail, Colorado, United States
• University of Washington — Seattle, Washington, United States
• University of Britich Columbia — Vancouver, British Columbia, Canada
• Rizzoli Orthopaedic Institute — Bologna, Italy
• Oslo Sports Trauma Research Center — Oslo, Norway

Full record on ClinicalTrials.gov

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