Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing - Full Text View

Sponsor:	Hospital for Special Surgery, New York
Collaborator:	Musculoskeletal Transplant Foundation
Information provided by:	Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:	NCT00198185

Purpose

Hypothesis: The use of cascade platelet-rich fibrin matrix (PRFM) on medium and large sized rotator cuff tears will improve patient results versus the control results by 50%.

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.

Condition	Intervention	Phase
Rotator Cuff Tendon Injuries	Procedure: Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	The Evaluation of Cascade PRFM on Rotator Cuff Healing

Resource links provided by NLM:

Drug Information available for: Fibrin

U.S. FDA Resources

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:

L'Insalata: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
American Shoulder and Elbow Surgery (ASES) Patient Survey: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively

Secondary Outcome Measures:

Ultrasound (power Doppler imaging): 6 weeks, 3 months post-operatively
Manual muscle testing using a dynamometer: preoperatively, 3 months post-operatively, 6 months post-operatively
ASES Physician Survey: preoperatively, 3 months post-operatively, 12 months post-operatively

Estimated Enrollment:	136
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients 45 years of age and older who have failed conservative treatment for rotator cuff pathology.
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:

Patients who have undergone revision procedures, mini-open, or open procedures will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198185

Contacts

Contact: Andrew D Pearle, MD	212 774 2333	pearlea@hss.edu
Contact: Cornelia Griggs, Bachelor's	212 774 7520	griggsc@hss.edu

Locations

United States, New York
Hospital for Special Surgery	Recruiting
New York City, New York, United States, 10021
Contact: Andrew D Pearle, MD 212-774-2333 pearlea@hss.edu
Contact: Cornelia Griggs, Bachelor's 212-774-7520 griggsc@hss.edu
Sub-Investigator: Andrew D Pearle, MD

Sponsors and Collaborators

Hospital for Special Surgery, New York

Musculoskeletal Transplant Foundation

Investigators

Principal Investigator:

Russell F. Warren, MD

Hospital for Special Surgery, New York

More Information

Publications:

Burkhart SS. Arthroscopic treatment of massive rotator cuff tears. Clin Orthop Relat Res. 2001 Sep;(390):107-18.

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.

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.

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.

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.

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.

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. 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. Review.

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.

Aspenberg P, Virchenko O. Platelet concentrate injection improves Achilles tendon repair in rats. Acta Orthop Scand. 2004 Feb;75(1):93-9.

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.

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.

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.

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. No abstract available.

ClinicalTrials.gov Identifier:	NCT00198185 History of Changes
Other Study ID Numbers:	24087
Study First Received:	September 12, 2005
Last Updated:	January 11, 2006
Health Authority:	United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:

Full Thickness Tendon Defect of Rotator Cuff

Additional relevant MeSH terms:

Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on February 13, 2012