Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma
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|ClinicalTrials.gov Identifier: NCT01406821|
Recruitment Status : Recruiting
First Posted : August 1, 2011
Last Update Posted : April 17, 2018
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
- Patient-reported improvement in symptoms at 12 weeks [ Time Frame: 12 weeks ]
- Reduction in patellar tendinosis by MRI [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406821
|Contact: Amy S Wasterlain||(718) firstname.lastname@example.org|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Jason L Dragoo, MD 650-721-3430 email@example.com|
|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 firstname.lastname@example.org|
|Sub-Investigator: Amy Wasterlain, MD|
|Principal Investigator: Eric Strauss, MD|
|Study Director:||Amy Sarah Wasterlain||Stanford University|
|Principal Investigator:||Dr. Jason L. Dragoo||Stanford University|