NCT02116946

Plasma Injections Plus Exercise for Patellar Tendinopathy

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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: 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.

Conditions

• Patellar Tendinopathy

Interventions

Type	Name	Description
BIOLOGICAL	Platelet Rich Plasma (PRP)	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.
OTHER	Saline + exercise	Peritendinous saline injection plus 12 week exercise program.

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2014-04-17
• Last updated: 2018-12-21

Locations

5 sites across 4 countries: United States, Canada, Italy, Norway