Trial record 16 of 70 for:    Open Studies | "Rotator Cuff"

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

This study is not yet open for participant recruitment.
Verified September 2012 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Brendan Mackinnonpatterson, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01688362
First received: September 14, 2012
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Rotator Cuff Tear.
Biological: Platelet Rich Plasma (PRP)
Drug: Corticosteroid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH) [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline six weeks, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Percent change in Visual Analog Pain scale (VAS) [ Time Frame: Baseline, six weeks, three months, six months, one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, six weeks, three months, six months, one year ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline, six months and one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688362

Contacts
Contact: Brendan C Mackinnon-Patterson, BS,MPH,MD 314-303-7300 bmackinn@unch.unc.edu

Locations
United States, North Carolina
University of North Carolina Department of Orthopaedics Not yet recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Mackinnon-Patterson       bmackinn@unch.unc.edu   
Principal Investigator: Brendan C Mackinnon-Patterson, BS, MPH, MD         
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
  More Information

Publications:

Responsible Party: Brendan Mackinnonpatterson, MD, Resident, Orthopaedic Surgery, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01688362     History of Changes
Other Study ID Numbers: 12-1016
Study First Received: September 14, 2012
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

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:
Lacerations
Rupture
Wounds and Injuries
Anesthetics, Local
Bupivacaine
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014