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Plasma Injections Plus Exercise for Patellar Tendinopathy (PHS)

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ClinicalTrials.gov Identifier: NCT02116946
Recruitment Status : Recruiting
First Posted : April 17, 2014
Last Update Posted : May 17, 2017
Sponsor:
Collaborators:
American Orthopaedic Society for Sports Medicine
University of Washington
Rizzoli Orthopaedic Institute
Norwegian Olympic Sports Center
University of Oslo
Steadman Clinic
Information provided by (Responsible Party):
Alexander Scott, University of British Columbia

April 9, 2014
April 17, 2014
May 17, 2017
March 2014
December 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02116946 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Patellar Tendinopathy
  • 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 Name: The device Angel cPRP System will be used to make (Leukocyte-rich or -poor) PRP injections
  • Other: Saline + exercise
    Peritendinous saline injection plus 12 week exercise program.
  • Experimental: Leukocyte-rich Platelet Rish Plasma + exercise
    Leukocyte-rich PRP injection and a 12 week exercise program.
    Intervention: Biological: Platelet Rich Plasma (PRP)
  • Experimental: Leukocyte-poor Platelet Rich Plasma + exercise
    Leukocyte-poor PRP injection and a 12 week exercise program.
    Intervention: Biological: Platelet Rich Plasma (PRP)
  • Placebo Comparator: Saline + exercise
    Saline injection and a 12 week exercise program.
    Intervention: Other: Saline + exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Same as current
December 2017
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Canada,   Italy,   Norway,   United States
 
 
NCT02116946
H13-00254
Yes
Not Provided
Not Provided
Alexander Scott, University of British Columbia
University of British Columbia
  • American Orthopaedic Society for Sports Medicine
  • University of Washington
  • Rizzoli Orthopaedic Institute
  • Norwegian Olympic Sports Center
  • University of Oslo
  • Steadman Clinic
Principal Investigator: Alexander Scott, PhD University of British Columbia
University of British Columbia
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP