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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Injection of Leukocyte-rich or Leukocyte-poor Platelet Rich Plasma prepared by the Angel cPRP System along with a 12 week exercise program for treatment of patients with patellar tendinopathy.
Peritendinous saline injection plus 12 week exercise program.
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
Clinical Efficacy
Number and frequency of adverse events will be assessed/reported weekly for the first 12 weeks and at the 6 month visit.
Time frame: 2 years
Change in function over time measured by VISA Score
To compare change in function (VISA score) between participants randomized to the three treatment groups over six months, 1 year, and 2 years of a post-injection exercise protocol.
Time frame: 2 years
Comparison of treatment success measured by Likert Global Improvement Scale
To compare change in treatment success (Likert global improvement scale) between participants randomized to the three treatment groups over six months, 1 year, and 2 years of a post-injection exercise protocol.
Time frame: 2 years
Change in activity levels over time measured by Tegner Activity Score
To compare change in activity levels (Tegner Activity Score) between participants randomized to the three groups over six months, 1 year, and 2 years of an exercise protocol.
Time frame: 2 years
Change in activity-related pain over time measured by Pain Numeric Rating Scale
To compare change in activity-related pain (Pain Numeric Rating Scale) between participants randomized to the three groups over six months, 1 year, and 2 years of an exercise protocol.
Time frame: 2 years
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