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

NCT ID: NCT01406821

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2019-03-15

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.

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.

Conditions

Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dry needling

Blood will be drawn, and tendon will be penetrated with dry needle. Nothing will be injected into the tendon.

Group Type: SHAM_COMPARATOR

Ultrasound-guided dry needling

Intervention Type: PROCEDURE

Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Nothing will be injected into the tendon.

Platelet-rich plasma (PRP)

Blood will be drawn, and platelet-rich plasma will be injected into the tendon.

Group Type: EXPERIMENTAL

Ultrasound-guided platelet-rich-plasma (PRP) injection

Intervention Type: PROCEDURE

Blood will be drawn, and platelet-rich plasma will be injected into the tendon under ultrasound guidance.

Interventions

Ultrasound-guided platelet-rich-plasma (PRP) injection

Blood will be drawn, and platelet-rich plasma will be injected into the tendon under ultrasound guidance.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jason L. Dragoo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Christina Herrero

Role: STUDY_DIRECTOR

New York University Langone Orthopedic Hospital

Dr. Jason L. Dragoo

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

New York University Langone Orthopedic Hospital

New York, New York, United States

Countries

United States

Other Identifiers

16595

Identifier Type: -

Identifier Source: secondary_id

SU-10162010-7109

Identifier Type: -

Identifier Source: org_study_id