Plasma Injections Plus Exercise for Patellar Tendinopathy

Phase 2

Terminated

Interventions: Biological: Platelet Rich Plasma (PRP)
Other: Saline + exercise

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Leukocyte-poor Platelet Rich Plasma + exercise	Platelet Rich Plasma (PRP)	Leukocyte-poor PRP injection and a 12 week exercise program.
Saline + exercise	Saline + exercise	Saline injection and a 12 week exercise program.
Leukocyte-rich Platelet Rish Plasma + exercise	Platelet Rich Plasma (PRP)	Leukocyte-rich PRP injection and a 12 week exercise program.

Primary Outcome Measures

Name	Time	Method
Clinical Efficacy	2 years	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

Name	Time	Method
Change in function over time measured by VISA Score	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	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	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	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.

Locations (5): University of Washington
🇺🇸
Seattle, Washington, United States
University of Britich Columbia
🇨🇦
Vancouver, British Columbia, Canada
The Steadman Clinic
🇺🇸
Vail, Colorado, United States
Rizzoli Orthopaedic Institute
🇮🇹
Bologna, Italy
Oslo Sports Trauma Research Center
🇳🇴
Oslo, Norway