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

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ClinicalTrials.gov Identifier: NCT01688362
Recruitment Status : Terminated (Did not meet target enrollment deadlines.)
First Posted : September 19, 2012
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : November 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids Tears

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH) [ Time Frame: 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 :
  1. Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH) [ Time Frame: baseline six weeks, 3 months, 6 months ]
  2. Percent change in Visual Analog Pain scale (VAS) [ Time Frame: 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).

  3. Percent change in American Shoulder and Elbow Surgeons (ASES) scale [ Time Frame: 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.

  4. Size of rotator cuff tear size. [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688362


Locations
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United States, North Carolina
University of North Carolina Department of Orthopaedics
Chapel Hill, North Carolina, United States, 27517
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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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
More Information
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Publications:
GlobalData. Platelet rich plasma: a market snapshot. http://www.docstoc.com/docs/47503668/Platelet-Rich-Plasma-A-Market-Snapshot. September 12, 2012.

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01688362    
Other Study ID Numbers: 12-1016
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: February 2016
Keywords provided by University of North Carolina, Chapel Hill:
Prospective Randomized Controlled Double Blinded Trial
Rotator Cuff Tear
Platelet Rich Plasma
Corticosteroid
Ultrasound
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Dexamethasone
Bupivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents