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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Stanford University
Sponsor:
Collaborator:
New York University School of Medicine
Information provided by (Responsible Party):
Jason L. Dragoo, Stanford University
ClinicalTrials.gov Identifier:
NCT01406821
First received: July 28, 2011
Last updated: October 12, 2016
Last verified: October 2016
  Purpose

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 Intervention
Tendinopathy
Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection
Procedure: Ultrasound-guided dry needling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Patient-reported improvement in symptoms at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in patellar tendinosis by MRI [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406821

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

Responsible Party: Jason L. Dragoo, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01406821     History of Changes
Other Study ID Numbers: SU-10162010-7109  16595 
Study First Received: July 28, 2011
Last Updated: October 12, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Stanford University:
tendinitis
tendonitis
PRP
platelet-rich-plasma
platelet
tendinosis
tendinopathy
enthesopathy
muscle
sport
tendon
patella
patellar tendon

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on December 09, 2016