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

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

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.

Study Overview

• Status: Completed
• Conditions: Tendinopathy
• Intervention / Treatment: Procedure: Ultrasound-guided dry needling; Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • New York
    • New York, New York, United States, 10003
      • New York University Langone Orthopedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient-reported improvement in symptoms at 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in patellar tendinosis by MRI	6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2009
• Primary Completion (ACTUAL): March 15, 2019
• Study Completion (ACTUAL): March 15, 2019

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (ESTIMATE): August 1, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: platelet; muscle; sport; tendon; PRP; tendinopathy; patella; tendinosis; tendinitis; tendonitis; enthesopathy; patellar tendon; platelet-rich-plasma
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: SU-10162010-7109; 16595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO