Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing
NCT ID: NCT00198185
Last Updated: 2018-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2005-01-31
2005-01-31
Brief Summary
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The purpose of this study is to examine the effect of PRFM on rotator cuff repairs. Since locally applied platelet-derived growth factor (PDGF) has shown early promise in enhancing tendon and ligament healing in anterior cruciate ligament (ACL) and medial collateral ligament (MCL) reconstruction, the investigators believe that locally applied PRFM will enhance the quality of rotator cuff repairs.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery
Eligibility Criteria
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Inclusion Criteria
* Patients in this study will have full thickness rotator cuff tears that are classified arthroscopically as medium (1 to 3 cm) or large (3 to 5 cm) and that are treated with arthroscopic repair.
Exclusion Criteria
45 Years
ALL
Yes
Sponsors
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Musculoskeletal Transplant Foundation
OTHER
Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Russell F. Warren, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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References
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Burkhart SS. Arthroscopic treatment of massive rotator cuff tears. Clin Orthop Relat Res. 2001 Sep;(390):107-18. doi: 10.1097/00003086-200109000-00013.
Burkhart SS, Danaceau SM, Pearce CE Jr. Arthroscopic rotator cuff repair: Analysis of results by tear size and by repair technique-margin convergence versus direct tendon-to-bone repair. Arthroscopy. 2001 Nov-Dec;17(9):905-12. doi: 10.1053/jars.2001.26821.
Tauro JC. Arthroscopic rotator cuff repair: analysis of technique and results at 2- and 3-year follow-up. Arthroscopy. 1998 Jan-Feb;14(1):45-51. doi: 10.1016/s0749-8063(98)70119-7.
Calvert PT, Packer NP, Stoker DJ, Bayley JI, Kessel L. Arthrography of the shoulder after operative repair of the torn rotator cuff. J Bone Joint Surg Br. 1986 Jan;68(1):147-50. doi: 10.1302/0301-620X.68B1.3941132.
Wilson F, Hinov V, Adams G. Arthroscopic repair of full-thickness tears of the rotator cuff: 2- to 14-year follow-up. Arthroscopy. 2002 Feb;18(2):136-44. doi: 10.1053/jars.2002.30443.
Harryman DT 2nd, Mack LA, Wang KY, Jackins SE, Richardson ML, Matsen FA 3rd. Repairs of the rotator cuff. Correlation of functional results with integrity of the cuff. J Bone Joint Surg Am. 1991 Aug;73(7):982-9.
Jost B, Pfirrmann CW, Gerber C, Switzerland Z. Clinical outcome after structural failure of rotator cuff repairs. J Bone Joint Surg Am. 2000 Mar;82(3):304-14. doi: 10.2106/00004623-200003000-00002.
Gazielly DF, Gleyze P, Montagnon C. Functional and anatomical results after rotator cuff repair. Clin Orthop Relat Res. 1994 Jul;(304):43-53.
Maffulli N, Moller HD, Evans CH. Tendon healing: can it be optimised? Br J Sports Med. 2002 Oct;36(5):315-6. doi: 10.1136/bjsm.36.5.315. No abstract available.
Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.
Nakamura N, Horibe S, Matsumoto N, Tomita T, Natsuume T, Kaneda Y, Shino K, Ochi T. Transient introduction of a foreign gene into healing rat patellar ligament. J Clin Invest. 1996 Jan 1;97(1):226-31. doi: 10.1172/JCI118395.
Aspenberg P, Virchenko O. Platelet concentrate injection improves Achilles tendon repair in rats. Acta Orthop Scand. 2004 Feb;75(1):93-9. doi: 10.1080/00016470410001708190.
Weiler A, Forster C, Hunt P, Falk R, Jung T, Unterhauser FN, Bergmann V, Schmidmaier G, Haas NP. The influence of locally applied platelet-derived growth factor-BB on free tendon graft remodeling after anterior cruciate ligament reconstruction. Am J Sports Med. 2004 Jun;32(4):881-91. doi: 10.1177/0363546503261711.
Yasuda K, Tomita F, Yamazaki S, Minami A, Tohyama H. The effect of growth factors on biomechanical properties of the bone-patellar tendon-bone graft after anterior cruciate ligament reconstruction: a canine model study. Am J Sports Med. 2004 Jun;32(4):870-80. doi: 10.1177/0363546503261695.
Liu SH, Baker CL. Arthroscopically assisted rotator cuff repair: correlation of functional results with integrity of the cuff. Arthroscopy. 1994 Feb;10(1):54-60. doi: 10.1016/s0749-8063(05)80293-2.
Mafulli, N, Benazzo F. Basic Sciences of Tendons. Sports Medicine and Arthroscopy Review, 8:1-5, 2000
Marx RE. Platelet-rich plasma (PRP): what is PRP and what is not PRP? Implant Dent. 2001;10(4):225-8. doi: 10.1097/00008505-200110000-00002. No abstract available.
Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012 Jun;40(6):1234-41. doi: 10.1177/0363546512442924. Epub 2012 Apr 10.
Other Identifiers
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24087
Identifier Type: -
Identifier Source: org_study_id
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