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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01406821
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
NYU Langone Health
Information provided by (Responsible Party):
Jason L. Dragoo, 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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 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
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

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.




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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406821


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, New York
New York University Langone Orthopedic Hospital
New York, New York, United States, 10003
Sponsors and Collaborators
Stanford University
NYU Langone Health
Investigators
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Study Director: Dr. Christina Herrero New York University Langone Orthopedic Hospital
Principal Investigator: Dr. Jason L. Dragoo Stanford University
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Responsible Party: Jason L. Dragoo, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01406821    
Other Study ID Numbers: SU-10162010-7109
16595
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jason L. Dragoo, Stanford University:
PRP
platelet-rich-plasma
platelet
tendinosis
tendinitis
tendonitis
tendinopathy
enthesopathy
muscle
sport
tendon
patella
patellar tendon
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries