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

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Terminated

CT.gov ID

NCT01688362

Collaborator

(none)

Enrollment

Location

Arms

17.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear	Biological: Platelet Rich Plasma (PRP) Drug: Corticosteroid	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Thickness Rotator Cuff Tears. A Randomized, Prospective, Double Blinded Trial.

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: platelet-rich plasma protein (PRP) Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks.	Biological: Platelet Rich Plasma (PRP) 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.
Active Comparator: Corticosteroid Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later.	Drug: Corticosteroid 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. Other Names: Bupivacaine Kenalog Dexamethasone

Arm

Intervention/Treatment

Experimental: platelet-rich plasma protein (PRP)

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

Biological: Platelet Rich Plasma (PRP)

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.

Active Comparator: Corticosteroid

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

Drug: Corticosteroid

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.

Other Names:

Bupivacaine

Kenalog

Dexamethasone

Outcome Measures

Primary Outcome Measures

Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH) [baseline and one year]
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) [baseline six weeks, 3 months, 6 months]
Percent change in Visual Analog Pain scale (VAS) [Baseline, six weeks, three months, six months, one year]
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 [Baseline, six weeks, three months, six months, one year]
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. [Baseline, six months and one year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina Department of Orthopaedics	Chapel Hill	North Carolina	United States	27517

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

Principal Investigator: Brendan C Mackinnon-Patterson, BS, MPH, MD, University of North Carolina Department of Orthopaedics
Study Director: Berkoff David, MD, University of North Carolina Department of Orthopaedics