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

Not Applicable

Completed

• Conditions: Tendinopathy
• Interventions: Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection; Procedure: Ultrasound-guided dry needling

• Registration Number: NCT01406821
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-01
• Status Verified: 2019-03
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-Acute or chronic ligament or tendon injuries

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet-rich plasma (PRP)	Ultrasound-guided platelet-rich-plasma (PRP) injection	Blood will be drawn, and platelet-rich plasma will be injected into the tendon.
Dry needling	Ultrasound-guided dry needling	Blood will be drawn, and tendon will be penetrated with dry needle. Nothing will be injected into the tendon.

Primary Outcome Measures

Name	Time	Method
Patient-reported improvement in symptoms at 12 weeks	12 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction in patellar tendinosis by MRI	6 months

Trial Locations

Locations (2)

New York University Langone Orthopedic Hospital; 🇺🇸 New York, New York, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States