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Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Rotator Cuff Tears

Primary Purpose

Rotator Cuff Tear

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Platelet Rich Plasma (PRP)
Corticosteroid
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Prospective Randomized Controlled Double Blinded Trial, Rotator Cuff Tear, Platelet Rich Plasma, Corticosteroid, Ultrasound

Eligibility Criteria

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

Inclusion Criteria:

  • Shoulder pain for at least two weeks.
  • Partial thickness articular sided rotator cuff tear diagnosed by MRI and musculoskeletal ultrasound.

Exclusion Criteria:

  • Prior surgery to the injured shoulder
  • Full thickness rotator cuff tear
  • Pregnancy
  • Cancer
  • Current treatment with anticoagulation medication
  • Steroid injection in the past 6 months in the injured shoulder
  • Prior PRP treatment to the injured shoulder

Sites / Locations

  • University of North Carolina Department of Orthopaedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

platelet-rich plasma protein (PRP)

Corticosteroid

Arm Description

Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks.

Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later.

Outcomes

Primary Outcome Measures

Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
Disabilities of the Arm, Shoulder, and Hand (DASH) is a 30-item self-reported questionnaire used assess shoulder function. The DASH is widely used in orthopaedic research and is considered valid and reliable.

Secondary Outcome Measures

Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
Percent change in Visual Analog Pain scale (VAS)
Visual Analog Pain scale (VAS) is a self-reported questionnaire used to measure a patients pain level on a scale from 0 (no pain) to 10 (extreme pain).
Percent change in American Shoulder and Elbow Surgeons (ASES) scale
American Shoulder and Elbow Surgeons (ASES) scale is used to measure shoulder function. It is combines both physician assessment and patient self-reported questionnaire date to create the functional score.
Size of rotator cuff tear size.
Rotator cuff tear size will be determined using ultrasound imaging. The mean size at six months and one year will be compared to baseline per-treatment size.

Full Information

First Posted
September 14, 2012
Last Updated
April 13, 2017
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01688362
Brief Title
Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Rotator Cuff Tears
Official Title
Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Thickness Rotator Cuff Tears. A Randomized, Prospective, Double Blinded Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Did not meet target enrollment deadlines.
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to further define the optimal non-surgical treatment strategy for partial thickness rotator cuff tears. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one year to determine the outcomes for each treatment. The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with corticosteroid injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Prospective Randomized Controlled Double Blinded Trial, Rotator Cuff Tear, Platelet Rich Plasma, Corticosteroid, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
platelet-rich plasma protein (PRP)
Arm Type
Experimental
Arm Description
Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks.
Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later.
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma (PRP)
Intervention Description
Subjects in this group will receive 2 injections with PRP. Subjects will have will have 15cc of blood drawn with the Arthrex ACP syringe. The blood will be placed into the Arthrex PRP centrifuge and spun at 1500 rpms for 5 minutes. The platelets will be drawn off to create the PRP for injection. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the PRP solution using a 22g needle. A dry sterile dressing will be placed on the injection site. This injection will Take place at time zero and then two weeks later it will be repeated.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Other Intervention Name(s)
Bupivacaine, Kenalog, Dexamethasone
Intervention Description
Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later. For the first injection patients will have 15ml of blood drawn. This blood will then be discarded in a biohazard container. A 6ml solution of 4ml 0.25% Bupivacaine, 1ml 40mg Kenalog, and 1ml 4mg Dexamethasone will be prepared. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the steroid solution using a 22g needle. A dry sterile dressing will be placed at the injection site. For the second injection two weeks later patients will have 15 ml of blood drawn. This blood will then be discarded in a biohazard container. Using the same technique as in Visit 2, the investigator will inject a 6 ml solution of 2 ml sterile normal saline with 4 ml 0.25% Bupivacaine to the shoulder using ultrasound. A dry sterile dressing will be placed at the injection site.
Primary Outcome Measure Information:
Title
Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
Description
Disabilities of the Arm, Shoulder, and Hand (DASH) is a 30-item self-reported questionnaire used assess shoulder function. The DASH is widely used in orthopaedic research and is considered valid and reliable.
Time Frame
baseline and one year
Secondary Outcome Measure Information:
Title
Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
Time Frame
baseline six weeks, 3 months, 6 months
Title
Percent change in Visual Analog Pain scale (VAS)
Description
Visual Analog Pain scale (VAS) is a self-reported questionnaire used to measure a patients pain level on a scale from 0 (no pain) to 10 (extreme pain).
Time Frame
Baseline, six weeks, three months, six months, one year
Title
Percent change in American Shoulder and Elbow Surgeons (ASES) scale
Description
American Shoulder and Elbow Surgeons (ASES) scale is used to measure shoulder function. It is combines both physician assessment and patient self-reported questionnaire date to create the functional score.
Time Frame
Baseline, six weeks, three months, six months, one year
Title
Size of rotator cuff tear size.
Description
Rotator cuff tear size will be determined using ultrasound imaging. The mean size at six months and one year will be compared to baseline per-treatment size.
Time Frame
Baseline, six months and one year

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: Shoulder pain for at least two weeks. Partial thickness articular sided rotator cuff tear diagnosed by MRI and musculoskeletal ultrasound. Exclusion Criteria: Prior surgery to the injured shoulder Full thickness rotator cuff tear Pregnancy Cancer Current treatment with anticoagulation medication Steroid injection in the past 6 months in the injured shoulder Prior PRP treatment to the injured shoulder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan C Mackinnon-Patterson, BS, MPH, MD
Organizational Affiliation
University of North Carolina Department of Orthopaedics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berkoff David, MD
Organizational Affiliation
University of North Carolina Department of Orthopaedics
Official's Role
Study Director
Facility Information:
Facility Name
University of North Carolina Department of Orthopaedics
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States

12. IPD Sharing Statement

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Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Rotator Cuff Tears

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