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

Primary Purpose

Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound-guided platelet-rich-plasma (PRP) injection
Ultrasound-guided dry needling
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring PRP, platelet-rich-plasma, platelet, tendinosis, tendinitis, tendonitis, tendinopathy, enthesopathy, muscle, sport, tendon, patella, patellar tendon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine
  • New York University Langone Orthopedic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Dry needling

Platelet-rich plasma (PRP)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Patient-reported improvement in symptoms at 12 weeks

Secondary Outcome Measures

Reduction in patellar tendinosis by MRI

Full Information

First Posted
July 28, 2011
Last Updated
March 27, 2019
Sponsor
Stanford University
Collaborators
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT01406821
Brief Title
Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma
Official Title
Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2009 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
NYU Langone Health

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
PRP, platelet-rich-plasma, platelet, tendinosis, tendinitis, tendonitis, tendinopathy, enthesopathy, muscle, sport, tendon, patella, patellar tendon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Sham Comparator
Arm Description
Blood will be drawn, and tendon will be penetrated with dry needle. Nothing will be injected into the tendon.
Arm Title
Platelet-rich plasma (PRP)
Arm Type
Experimental
Arm Description
Blood will be drawn, and platelet-rich plasma will be injected into the tendon.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided platelet-rich-plasma (PRP) injection
Intervention Description
Blood will be drawn, and platelet-rich plasma will be injected into the tendon under ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided dry needling
Intervention Description
Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Nothing will be injected into the tendon.
Primary Outcome Measure Information:
Title
Patient-reported improvement in symptoms at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction in patellar tendinosis by MRI
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Christina Herrero
Organizational Affiliation
New York University Langone Orthopedic Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dr. Jason L. Dragoo
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
New York University Langone Orthopedic Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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