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Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma
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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 Intervention Model: Parallel Assignment Masking: Double Blind (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 |
- Patient-reported improvement in symptoms at 12 weeks [ Time Frame: 12 weeks ]
- Reduction in patellar tendinosis by MRI [ Time Frame: 6 months ]
| 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) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01406821
| Contact: Amy S Wasterlain | (718) 644-5731 | awasterl@stanford.edu |
| 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 | |
| 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 |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on June 22, 2017