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
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
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
NCT ID
NCT01688362
First Posted
September 14, 2012
Last Updated
April 13, 2017
Sponsor
University of North Carolina, Chapel Hill
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
Citations:
PubMed Identifier
17148619
Citation
Wolff AB, Sethi P, Sutton KM, Covey AS, Magit DP, Medvecky M. Partial-thickness rotator cuff tears. J Am Acad Orthop Surg. 2006 Dec;14(13):715-25. doi: 10.5435/00124635-200612000-00003.
Results Reference
background
PubMed Identifier
16551396
Citation
Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968.
Results Reference
background
PubMed Identifier
7822341
Citation
Sher JS, Uribe JW, Posada A, Murphy BJ, Zlatkin MB. Abnormal findings on magnetic resonance images of asymptomatic shoulders. J Bone Joint Surg Am. 1995 Jan;77(1):10-5. doi: 10.2106/00004623-199501000-00002.
Results Reference
background
PubMed Identifier
7706351
Citation
Milgrom C, Schaffler M, Gilbert S, van Holsbeeck M. Rotator-cuff changes in asymptomatic adults. The effect of age, hand dominance and gender. J Bone Joint Surg Br. 1995 Mar;77(2):296-8.
Results Reference
background
PubMed Identifier
15069134
Citation
Teefey SA, Rubin DA, Middleton WD, Hildebolt CF, Leibold RA, Yamaguchi K. Detection and quantification of rotator cuff tears. Comparison of ultrasonographic, magnetic resonance imaging, and arthroscopic findings in seventy-one consecutive cases. J Bone Joint Surg Am. 2004 Apr;86(4):708-16.
Results Reference
background
PubMed Identifier
22241606
Citation
Sheth U, Simunovic N, Klein G, Fu F, Einhorn TA, Schemitsch E, Ayeni OR, Bhandari M. Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis. J Bone Joint Surg Am. 2012 Feb 15;94(4):298-307. doi: 10.2106/JBJS.K.00154.
Results Reference
background
Citation
GlobalData. Platelet rich plasma: a market snapshot. http://www.docstoc.com/docs/47503668/Platelet-Rich-Plasma-A-Market-Snapshot. September 12, 2012.
Results Reference
background
PubMed Identifier
22366517
Citation
Jo CH, Kim JE, Yoon KS, Shin S. Platelet-rich plasma stimulates cell proliferation and enhances matrix gene expression and synthesis in tenocytes from human rotator cuff tendons with degenerative tears. Am J Sports Med. 2012 May;40(5):1035-45. doi: 10.1177/0363546512437525. Epub 2012 Feb 23.
Results Reference
background
PubMed Identifier
22694941
Citation
Chahal J, Van Thiel GS, Mall N, Heard W, Bach BR, Cole BJ, Nicholson GP, Verma NN, Whelan DB, Romeo AA. The role of platelet-rich plasma in arthroscopic rotator cuff repair: a systematic review with quantitative synthesis. Arthroscopy. 2012 Nov;28(11):1718-27. doi: 10.1016/j.arthro.2012.03.007. Epub 2012 Jun 12.
Results Reference
background
PubMed Identifier
21570659
Citation
Randelli P, Arrigoni P, Ragone V, Aliprandi A, Cabitza P. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up. J Shoulder Elbow Surg. 2011 Jun;20(4):518-28. doi: 10.1016/j.jse.2011.02.008.
Results Reference
background
PubMed Identifier
21160018
Citation
Castricini R, Longo UG, De Benedetto M, Panfoli N, Pirani P, Zini R, Maffulli N, Denaro V. Platelet-rich plasma augmentation for arthroscopic rotator cuff repair: a randomized controlled trial. Am J Sports Med. 2011 Feb;39(2):258-65. doi: 10.1177/0363546510390780. Epub 2010 Dec 15.
Results Reference
background
PubMed Identifier
20448192
Citation
Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.
Results Reference
background
PubMed Identifier
21422467
Citation
Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.
Results Reference
background
PubMed Identifier
21705157
Citation
Wolf JM, Ozer K, Scott F, Gordon MJ, Williams AE. Comparison of autologous blood, corticosteroid, and saline injection in the treatment of lateral epicondylitis: a prospective, randomized, controlled multicenter study. J Hand Surg Am. 2011 Aug;36(8):1269-72. doi: 10.1016/j.jhsa.2011.05.014. Epub 2011 Jun 25.
Results Reference
background
PubMed Identifier
20068208
Citation
de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986.
Results Reference
background
PubMed Identifier
21602565
Citation
de Jonge S, de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. One-year follow-up of platelet-rich plasma treatment in chronic Achilles tendinopathy: a double-blind randomized placebo-controlled trial. Am J Sports Med. 2011 Aug;39(8):1623-9. doi: 10.1177/0363546511404877. Epub 2011 May 21.
Results Reference
background
PubMed Identifier
15701612
Citation
Alvarez CM, Litchfield R, Jackowski D, Griffin S, Kirkley A. A prospective, double-blind, randomized clinical trial comparing subacromial injection of betamethasone and xylocaine to xylocaine alone in chronic rotator cuff tendinosis. Am J Sports Med. 2005 Feb;33(2):255-62. doi: 10.1177/0363546504267345.
Results Reference
background
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Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Rotator Cuff Tears
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