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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Tendinopathy	Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection; Procedure: Ultrasound-guided dry needling	Not Applicable

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis
Actual Study Start Date :	August 2009
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2019

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Sham Comparator: Dry needling; Blood will be drawn, and tendon will be penetrated with dry needle. Nothing will be injected into the tendon.	Procedure: Ultrasound-guided dry needling; Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Nothing will be injected into the tendon.
Experimental: Platelet-rich plasma (PRP); Blood will be drawn, and platelet-rich plasma will be injected into the tendon.	Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection; Blood will be drawn, and platelet-rich plasma will be injected into the tendon under ultrasound guidance.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Patient-reported improvement in symptoms at 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Reduction in patellar tendinosis by MRI [ Time Frame: 6 months ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Amy S Wasterlain	(718) 644-5731	awasterl@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Jason L Dragoo, MD 650-721-3430 jdragoo@stanford.edu
Principal Investigator: Jason L Dragoo, MD
United States, New York
NYU Hospital for Joint Diseases	Recruiting
New York, New York, United States, 10003
Contact: Amy S Wasterlain, MD 718-644-5731 amy.wasterlain@nyumc.org
Sub-Investigator: Amy Wasterlain, MD
Principal Investigator: Eric Strauss, MD

Sponsors and Collaborators

Stanford University

New York University School of Medicine

Investigators

Study Director:	Amy Sarah Wasterlain	Stanford University
Principal Investigator:	Dr. Jason L. Dragoo	Stanford University

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Jason L. Dragoo, Associate Professor, Stanford University
ClinicalTrials.gov Identifier:	NCT01406821 History of Changes
Other Study ID Numbers:	SU-10162010-7109; 16595
First Posted:	August 1, 2011
Last Update Posted:	April 17, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Jason L. Dragoo, Stanford University:

tendinopathy; PRP; platelet-rich-plasma; platelet; tendinosis; tendinitis; tendonitis	enthesopathy; muscle; sport; tendon; patella; patellar tendon

Additional relevant MeSH terms:

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries