Plasma Injections Plus Exercise for Patellar Tendinopathy

Study Overview
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Brief Summary
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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.

Official Title
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Intratendinous Injections of Platelet Rich Plasma With or Without Leukocyte Enrichment for Patellar Tendinopathy: a Randomized Controlled Trial

Conditions
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Patellar Tendinopathy

Intervention / Treatment
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* Biological: Platelet Rich Plasma (PRP)
* Other: Saline + exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leukocyte-rich Platelet Rish Plasma + exercise<br>Leukocyte-rich PRP injection and a 12 week exercise program. | Biological: Platelet Rich Plasma (PRP)<br>* 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.<br>* Other names: The device Angel cPRP System will be used to make (Leukocyte-rich or -poor) PRP injections;|
| Experimental: Leukocyte-poor Platelet Rich Plasma + exercise<br>Leukocyte-poor PRP injection and a 12 week exercise program. | Biological: Platelet Rich Plasma (PRP)<br>* 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.<br>* Other names: The device Angel cPRP System will be used to make (Leukocyte-rich or -poor) PRP injections;|
| Placebo Comparator: Saline + exercise<br>Saline injection and a 12 week exercise program. | Other: Saline + exercise<br>* Peritendinous saline injection plus 12 week exercise program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Efficacy | Number and frequency of adverse events will be assessed/reported weekly for the first 12 weeks and at the 6 month visit. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 
| 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. | 2 years | 
| 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. | 2 years | 
| 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. | 2 years |