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Plasma Injections Plus Exercise for Patellar Tendinopathy (PHS)

Primary Purpose

Patellar Tendinopathy

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Platelet Rich Plasma (PRP)
Saline + exercise
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Tendinopathy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Steadman Clinic
  • University of Washington
  • University of Britich Columbia
  • Rizzoli Orthopaedic Institute
  • Oslo Sports Trauma Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Leukocyte-rich Platelet Rish Plasma + exercise

Leukocyte-poor Platelet Rich Plasma + exercise

Saline + exercise

Arm Description

Leukocyte-rich PRP injection and a 12 week exercise program.

Leukocyte-poor PRP injection and a 12 week exercise program.

Saline injection and a 12 week exercise program.

Outcomes

Primary Outcome Measures

Clinical Efficacy
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
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
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
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
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.

Full Information

First Posted
April 9, 2014
Last Updated
December 19, 2018
Sponsor
University of British Columbia
Collaborators
American Orthopaedic Society for Sports Medicine, University of Washington, Rizzoli Orthopaedic Institute, Norwegian Olympic Sports Center, University of Oslo, Steadman Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02116946
Brief Title
Plasma Injections Plus Exercise for Patellar Tendinopathy
Acronym
PHS
Official Title
Intratendinous Injections of Platelet Rich Plasma With or Without Leukocyte Enrichment for Patellar Tendinopathy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
79% participant retention after 1 year
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
American Orthopaedic Society for Sports Medicine, University of Washington, Rizzoli Orthopaedic Institute, Norwegian Olympic Sports Center, University of Oslo, Steadman Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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: Leukocyte-rich PRP injection + exercise Leukocyte-poor PRP injection + exercise 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leukocyte-rich Platelet Rish Plasma + exercise
Arm Type
Experimental
Arm Description
Leukocyte-rich PRP injection and a 12 week exercise program.
Arm Title
Leukocyte-poor Platelet Rich Plasma + exercise
Arm Type
Experimental
Arm Description
Leukocyte-poor PRP injection and a 12 week exercise program.
Arm Title
Saline + exercise
Arm Type
Placebo Comparator
Arm Description
Saline injection and a 12 week exercise program.
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma (PRP)
Other Intervention Name(s)
The device Angel cPRP System will be used to make (Leukocyte-rich or -poor) PRP injections
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline + exercise
Intervention Description
Peritendinous saline injection plus 12 week exercise program.
Primary Outcome Measure Information:
Title
Clinical Efficacy
Description
Number and frequency of adverse events will be assessed/reported weekly for the first 12 weeks and at the 6 month visit.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in function over time measured by VISA Score
Description
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.
Time Frame
2 years
Title
Comparison of treatment success measured by Likert Global Improvement Scale
Description
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.
Time Frame
2 years
Title
Change in activity levels over time measured by Tegner Activity Score
Description
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.
Time Frame
2 years
Title
Change in activity-related pain over time measured by Pain Numeric Rating Scale
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Scott, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Steadman Clinic
City
Vail
State/Province
Colorado
ZIP/Postal Code
81657
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Britich Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
Facility Name
Rizzoli Orthopaedic Institute
City
Bologna
Country
Italy
Facility Name
Oslo Sports Trauma Research Center
City
Oslo
Country
Norway

12. IPD Sharing Statement

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Plasma Injections Plus Exercise for Patellar Tendinopathy

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