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

Tendinopathy Clinical Trial

Official title:

Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406821
• Other study ID #: SU-10162010-7109
• Secondary ID: 16595
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University Langone Orthopedic Hospital	New York	New York
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported improvement in symptoms at 12 weeks		12 weeks
Secondary	Reduction in patellar tendinosis by MRI		6 months