MedTrace Logo

Plasma Injections Plus Exercise for Patellar Tendinopathy

NCT02116946 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-12-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • American Orthopaedic Society for Sports Medicine

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Rizzoli Orthopaedic Institute

    collaborator UNKNOWN

  • Norwegian Olympic Sports Center

    collaborator UNKNOWN

  • University of Oslo

    collaborator OTHER

  • Steadman Clinic

    collaborator UNKNOWN

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Alexander Scott, PhD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States
  • Canada
  • Italy
  • Norway

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116946 on ClinicalTrials.gov