Plasma Injections Plus Exercise for Patellar Tendinopathy
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 12/23/2018 |
| Start Date: | March 2014 |
| End Date: | December 2018 |
Intratendinous Injections of Platelet Rich Plasma With or Without Leukocyte Enrichment for Patellar Tendinopathy: a Randomized Controlled Trial
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.
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.
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
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