Clinical trial NCT02116946: Plasma Injections Plus Exercise for Patellar Tendinopathy
Official title: Intratendinous Injections of Platelet Rich Plasma With or Without Leukocyte Enrichment for Patellar Tendinopathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Patellar Tendinopathy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: American Orthopaedic Society for Sports Medicine
name: University of Washington
name: Rizzoli Orthopaedic Institute
name: Norwegian Olympic Sports Center
name: University of Oslo
name: Steadman Clinic
First posted: 2014-04-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


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

Primary outcomes:
measure: Clinical Efficacy
timeFrame: 2 years
Secondary outcomes:
measure: Change in function over time measured by VISA Score
timeFrame: 2 years
measure: Comparison of treatment success measured by Likert Global Improvement Scale
timeFrame: 2 years
measure: Change in activity levels over time measured by Tegner Activity Score
timeFrame: 2 years
measure: Change in activity-related pain over time measured by Pain Numeric Rating Scale
timeFrame: 2 years
Other outcomes:
Locations:
city: Vail
country: United States
facility: The Steadman Clinic
state: Colorado
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Vancouver
country: Canada
facility: University of Britich Columbia
state: British Columbia
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
city: Oslo
country: Norway
facility: Oslo Sports Trauma Research Center
Study officials:
affiliation: University of British Columbia
name: Alexander Scott, PhD
role: PRINCIPAL_INVESTIGATOR
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