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Completed

NCT Number: NCT01406821

Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma

Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function.

We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine, Stanford, California, United States

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About this study

Pre-procedure diagnosis: The appropriate clinical evaluation will be dictated by the examining physician. Minimal pre-procedure studies will include plain radiographs and MRI. All patients will complete a pretreatment questionnaire.

Patients will be randomized and blinded to a treatment regimen.

Method of randomization: Some of the participating subjects will receive platelet rich plasma and others will receive a saline injection. The platelet rich plasma experimental group will have up to 50cc of whole blood collected via venipuncture and prepared using the standard PRP protocol.

To blind the control group these patients will have a simulated needle stick and approximately 10 ml (2 teaspoons) of blood will be drawn. No blood will be given back to the patient. For those in the control group their ligament or tendon will be stimulated with dry needling (moving a needle up and down in the tendon, without injection). Patients in the PRP treatment group will also have dry needling, plus the PRP will be injected into the tendon as well.

Platelet rich plasma injections have an equivalent risk profile to routine injections. Those potential risks include skin discoloration, pain at injection site, superficial or deep infection, no relief of symptoms, worsening of symptoms, and damage to nerve and blood vessels. Potential benefits include significant improvement in symptoms and reduction in time for return to function.

Post injection activity: All patients will use crutches for 24-48 hours after injection. All patients will have physical therapy two times a week according to a standardized protocol.

Follow up at the clinic for all patients will be every 3 weeks from weeks 1-12. All patients will fill out an injury location specific questionnaire, Tegner Activity Scale, short form-12, and visual analog scale for pain, among others. Additional follow-up will be done at 6 months, 1 year and 2 years. All radiographic studies will be read by a radiologist blinded to the study groups.

The primary endpoint for all patients in the study will be twelve weeks. Secondary enpoints are 6 months, 1 year and 2 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Acute or chronic ligament or tendon injuries

Exclusion criteria

  • Pregnant women,
  • children,
  • other injuries that require surgical intervention,
  • associated fractures,
  • systemic disease resulting in an immunocompromised state affecting ability to heal soft tissues

Treatment and study plan

Ultrasound-guided platelet-rich-plasma (PRP) injection

Procedure

Blood will be drawn, and platelet-rich plasma will be injected into the tendon under ultrasound guidance.

Ultrasound-guided dry needling

Procedure

Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Nothing will be injected into the tendon.

Primary outcomes

  1. Patient-reported improvement in symptoms at 12 weeks

    Time frame: 12 weeks

Secondary outcomes

  1. Reduction in patellar tendinosis by MRI

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • NYU Langone Health

Registry information

Official study title

Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2011
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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