Plasma Injections Plus Exercise for Patellar Tendinopathy (PHS)

University of British Columbia

Status and phase: Terminated; Phase 2

Conditions: Patellar Tendinopathy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02116946

H13-00254

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 3 patient groups, including a placebo group

Leukocyte-rich Platelet Rish Plasma + exercise

Experimental group

Description:

Leukocyte-rich PRP injection and a 12 week exercise program.

Treatment:

Biological: Platelet Rich Plasma (PRP)

Leukocyte-poor Platelet Rich Plasma + exercise

Experimental group

Description:

Leukocyte-poor PRP injection and a 12 week exercise program.

Treatment:

Biological: Platelet Rich Plasma (PRP)

Saline + exercise

Placebo Comparator group

Description:

Saline injection and a 12 week exercise program.

Treatment:

Other: Saline + exercise