Plasma Injections Plus Exercise for Patellar Tendinopathy (PHS)

December 19, 2018 updated by: Alexander Scott, University of British Columbia

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z4
        • University of Britich Columbia
  • Italy
      • Bologna, Italy
        • Rizzoli Orthopaedic Institute
  • Norway
      • Oslo, Norway
        • Oslo Sports Trauma Research Center
  • United States
    • Colorado
      • Vail, Colorado, United States, 81657
        • The Steadman Clinic
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Leukocyte-rich Platelet Rish Plasma + exercise
Leukocyte-rich PRP injection and a 12 week exercise program.
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 Names:
  • The device Angel cPRP System will be used to make (Leukocyte-rich or -poor) PRP injections
Experimental: Leukocyte-poor Platelet Rich Plasma + exercise
Leukocyte-poor PRP injection and a 12 week exercise program.
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 Names:
  • The device Angel cPRP System will be used to make (Leukocyte-rich or -poor) PRP injections
Placebo Comparator: Saline + exercise
Saline injection and a 12 week exercise program.
Other: Saline + exercise
Peritendinous saline injection plus 12 week exercise program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in function over time measured by VISA Score
Time Frame: 2 years
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.
2 years
Comparison of treatment success measured by Likert Global Improvement Scale
Time Frame: 2 years
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.
2 years
Change in activity levels over time measured by Tegner Activity Score
Time Frame: 2 years
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.
2 years
Change in activity-related pain over time measured by Pain Numeric Rating Scale
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

University of Oslo
University of Washington
American Orthopaedic Society for Sports Medicine
Rizzoli Orthopaedic Institute
Norwegian Olympic Sports Center
Steadman Clinic

Investigators

  • Principal Investigator: Alexander Scott, PhD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 17, 2014

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-00254

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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