Patellar Tendinopathy
Conditions
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.
Interventions
BIOLOGICALPlatelet 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.
OTHERSaline + exercise
Peritendinous saline injection plus 12 week exercise program.
Sponsors
American Orthopaedic Society for Sports Medicine
University of Washington
Rizzoli Orthopaedic Institute
Norwegian Olympic Sports Center
University of Oslo
Steadman Clinic
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada, Italy, Norway, United States
Outcome results
None listed