Treatment of Acute and Chronic Ligament and Tendon Injuri...

http://clinicaltrials.gov/ct2/show/study/NCT01406821

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Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma
This study is currently recruiting participants.
Veried on July 2011 by Stanford University First Received on July 28, 2011. Last Updated on July 29, 2011 History of Changes Sponsor: Information provided by: ClinicalTrials.gov Identier:

Stanford University Stanford University NCT01406821

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

Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classication: Efcacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment Ofcial Title: Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis

Resource links provided by NLM: MedlinePlus related topics: Tendinitis Ultrasound U.S. FDA Resources 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

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Treatment of Acute and Chronic Ligament and Tendon Injuri...

http://clinicaltrials.gov/ct2/show/study/NCT01406821

Study Start Date: August 2009 Estimated Study Completion Date: June 2012 Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure) Arms Dry needling: Sham Comparator Blood will be drawn, and tendon will be penetrated with dry needle. Nothing will be injected into the tendon. Intervention: Procedure: Ultrasound-guided dry needling Platelet-rich plasma (PRP): Experimental Blood will be drawn, and platelet-rich plasma will be injected into the tendon. Intervention: Procedure: Ultrasound-guided plateletrich-plasma (PRP) injection Assigned Interventions 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.

Procedure: Ultrasound-guided plateletrich-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 the 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 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 10 ml (2 teaspoons) of blood will be drawn to test for growth factors. No blood will be given back to the patient. For those in the control group their ligament or tendon will be injected with saline. The staff nurse will place the blood (experimental group) or saline (control group) in syringes and the treating physician and patient will be blinded to the treatment. Platelet rich plasma injections have an equivalent risk prole to routine injections. Those potential risks include skin discoloration, pain at injection site, supercial or deep infection, no relief of symptoms, worsening of symptoms, and damage to nerve and blood vessels. Potential benets include signicant improvement in symptoms and reduction in time for return to function. Post injection activity: All patients will be non-weight bearing 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 other week from week 1-12. All patients will ll out an injury location specic questionnaire, Tegner Activity Scale, short form-12, and visual analog scale for pain. All radiographic studies will be read by one Stanford radiologist blinded to the study groups. The endpoint for all patients in the study will be twelve weeks.

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Treatment of Acute and Chronic Ligament and Tendon Injuri...

http://clinicaltrials.gov/ct2/show/study/NCT01406821

Eligibility
Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: 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 18 Years to 65 Years Both No

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identier: 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: Amy S Wasterlain 718-644-5731 awasterl@stanford.edu Contact: Jason L Dragoo, MD (650) 721-3430 jdragoo@stanford.edu Principal Investigator: Dr. Jason L. Dragoo Study Director: Amy Sarah Wasterlain Sponsors and Collaborators Stanford University Investigators Study Director: Amy Sarah Wasterlain Stanford University Stanford University Principal Investigator: Dr. Jason L. Dragoo

More Information
No publications provided Responsible Party: ClinicalTrials.gov Identier: Other Study ID Numbers: Study First Received: Last Updated: Health Authority: Dr. Jason L. Dragoo, Stanford University School of Medicine NCT01406821 History of Changes SU-10162010-7109, 16595 July 28, 2011 July 29, 2011 United States: Institutional Review Board enthesopathy muscle sport tendon patella patellar tendon

Keywords provided by Stanford University: PRP platelet-rich-plasma platelet tendinosis tendinitis tendonitis tendinopathy Additional relevant MeSH terms: Tendinopathy

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Treatment of Acute and Chronic Ligament and Tendon Injuri...

http://clinicaltrials.gov/ct2/show/study/NCT01406821

Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries ClinicalTrials.gov processed this record on January 04, 2012
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