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Platelet-Rich Plasma (PRP) Injection for the Treatment of Chronic Patellar Tendinopathy

NCT01843504 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-04-26

No results posted yet for this study

Summary

The goal of this study is to find an effective treatment for chronic patellar tendinopathy (PT). Investigators will conduct a 32-week randomized controlled clinical trial to determine whether platelet rich plasma (PRP) injections improve disease-specific clinical outcomes with correlation to a new method of ultrasound (US) imaging assessment called Acoustoelastography (AE). Positive findings of PRP compared to control would suggest future larger scale studies to help establish an optimal protocol for the nonsurgical management of PT.

Conditions

  • Chronic Patellar Tendinopathy
  • Chronic PT

Interventions

BIOLOGICAL

platelet rich plasma

A blood draw of 15 mL of the subject's own blood will be performed. The study coordinator will then place the sample in the Platelet Separator System (a centrifuge) and spin the blood sample in using a two-stage spinning: the 1st separates red blood cells from platelets, and the 2nd concentrates the platelets. This will be spun by centrifuge to yield 6 mL of concentrated autologous platelet. Under continuous ultrasound evaluation, 1.0-2.0 mL of the prepared PRP will be injected onto the origin of the patella tendon itself will be peppered along a short segment of the tendon into the areas of palpated tenderness and US-documented pathology.

OTHER

saline

A blood draw of 15 mL of the subject's own blood will be performed to maintain blinding. Under continuous ultrasound evaluation, 1.0-2.0 mL of the saline solution will be injected onto the origin of the patella tendon itself will be peppered along a short segment of the tendon into the areas of palpated tenderness and US-documented pathology.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • John J. Wilson, MD, MS · UW-Madison School of Medicine & Public Health

  • Stephen J. Almasi, MD · UW-Madison School of Medicine & Public Health

  • Kenneth S. Lee, MD · UW-Madison School of Medicine & Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2024-02-29
Completion
2024-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01843504 on ClinicalTrials.gov