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

NCT00198185 | Withdrawn Phase 3

• 1 other identifier: 24087
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff; Tendon Injuries

Keywords

Full Thickness Tendon Defect of Rotator Cuff

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Interventions

Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery PROCEDURE

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Musculoskeletal Transplant Foundation: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (18)

• Burkhart SS. Arthroscopic treatment of massive rotator cuff tears. Clin Orthop Relat Res. 2001 Sep;(390):107-18. doi: 10.1097/00003086-200109000-00013.

  PMID: 11550856 BACKGROUND

• 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.

  PMID: 11694920 BACKGROUND

• 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.

  PMID: 9486332 BACKGROUND

• 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.

  PMID: 3941132 BACKGROUND

• 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.

  PMID: 11830806 BACKGROUND

• 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.

  PMID: 1874784 BACKGROUND

• 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.

  PMID: 10724223 BACKGROUND

• Gazielly DF, Gleyze P, Montagnon C. Functional and anatomical results after rotator cuff repair. Clin Orthop Relat Res. 1994 Jul;(304):43-53.

  PMID: 8020233 BACKGROUND

• 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.

  PMID: 12351325 BACKGROUND

• 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.

  PMID: 12696985 BACKGROUND

• 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.

  PMID: 8550839 BACKGROUND

• 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.

  PMID: 15022816 BACKGROUND

• 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.

  PMID: 15150033 BACKGROUND

• 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.

  PMID: 15150032 BACKGROUND

• 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.

  PMID: 8166903 BACKGROUND

• Mafulli, N, Benazzo F. Basic Sciences of Tendons. Sports Medicine and Arthroscopy Review, 8:1-5, 2000

  BACKGROUND

• 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.

  PMID: 11813662 BACKGROUND

• 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.

  PMID: 22495146 DERIVED

MeSH Terms

Conditions

Tendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Russell F. Warren, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: January 4, 2018

Record last verified: 2018-01

Locations

US (1)