Clinical trial NCT01688362: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Rotator Cuff Tear
Keywords: Prospective Randomized Controlled Double Blinded Trial
Rotator Cuff Tear
Platelet Rich Plasma
Corticosteroid
Ultrasound
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
timeFrame: baseline and one year
Secondary outcomes:
measure: Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
timeFrame: baseline six weeks, 3 months, 6 months
measure: Percent change in Visual Analog Pain scale (VAS)
timeFrame: Baseline, six weeks, three months, six months, one year
measure: Percent change in American Shoulder and Elbow Surgeons (ASES) scale
timeFrame: Baseline, six weeks, three months, six months, one year
measure: Size of rotator cuff tear size.
timeFrame: Baseline, six months and one year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Department of Orthopaedics
state: North Carolina
Study officials:
affiliation: University of North Carolina Department of Orthopaedics
name: Brendan C Mackinnon-Patterson, BS, MPH, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina Department of Orthopaedics
name: Berkoff David, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
citation: GlobalData. Platelet rich plasma: a market snapshot. http://www.docstoc.com/docs/47503668/Platelet-Rich-Plasma-A-Market-Snapshot. September 12, 2012.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.