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Plasma Injections Plus Exercise for Patellar Tendinopathy (PHS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of British Columbia
Sponsor:
Collaborators:
American Orthopaedic Society for Sports Medicine
University of Washington
Rizzoli Orthopaedic Institute, Italy
Norwegian Olympic Training Center, Norway
University of Oslo, Norway
Steadman-Hawkins Clinic
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02116946
First received: April 9, 2014
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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.

Condition Intervention
Patellar Tendinopathy
Biological: Platelet Rich Plasma (PRP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Intratendinous Injections of Platelet Rich Plasma With or Without Leukocyte Enrichment for Patellar Tendinopathy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Clinical Efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Number and frequency of adverse events will be assessed/reported weekly for the first 12 weeks and at the 6 month visit.


Secondary Outcome Measures:
  • Change in function over time measured by VISA Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: March 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02116946

Locations
United States, Colorado
The Steadman Clinic Not yet recruiting
Vail, Colorado, United States, 81657
Contact: Robert LaPrade, MD, PhD    970-479-5881    rlaprade@thesteadmanclinic.com   
Principal Investigator: Robert Laprade, MD, PhD         
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Kimberly Harmon, MD    206-520-5000    kharmon@uw.edu   
Principal Investigator: Kimberly Harmon, MD         
Canada, British Columbia
University of Britich Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V6T 1Z4
Contact: Alex Scott, PhD    604-875-4111 ext 21810    alex.scott@ubc.ca   
Principal Investigator: Alex Scott, PhD         
Italy
Rizzoli Orthopaedic Institute Not yet recruiting
Bologna, Italy
Contact: Elizaveta Kon, MD    39-051-6366567    e.kon@biomec.ior.it   
Principal Investigator: Elizaveta Kon, MD         
Norway
Oslo Sports Trauma Research Center Recruiting
Oslo, Norway
Contact: Lars Engebretsen, MD, PhD    47 22 85 50 50    lars.engebretsen@medisin.uio.no   
Principal Investigator: Lars Engebretsen, MD, PhD         
Sub-Investigator: Roald Bahr, MD, PhD         
Sponsors and Collaborators
University of British Columbia
American Orthopaedic Society for Sports Medicine
University of Washington
Rizzoli Orthopaedic Institute, Italy
Norwegian Olympic Training Center, Norway
University of Oslo, Norway
Steadman-Hawkins Clinic
Investigators
Principal Investigator: Alexander Scott, PhD University of British Columbia
  More Information

Publications:
Engebretsen, L, K Steffen, J Alsousou et al. IOC consensus paper on the use of platelet-rich plasma in sports medicine. Br J Sports Med 2010; 44: (15) 1072-81.
Kongsgaard, M, K Qvortrup, J Larsen et al. Fibril morphology and tendon mechanical properties in patellar tendinopathy: effects of heavy slow resistance training. Am J Sports Med 2010; 38: (4) 749-56.
Thanasas, C, G Papadimitriou, C Charalambidis et al. Platelet-rich plasma versus autologous whole blood for the treatment of chronic lateral elbow epicondylitis: a randomized controlled clinical trial. Am J Sports Med 2011; 39: (10) 2130-4.

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02116946     History of Changes
Other Study ID Numbers: H13-00254
Study First Received: April 9, 2014
Last Updated: October 17, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014