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

Tendon Injuries Clinical Trial

Official title:

The Evaluation of Cascade PRFM on Rotator Cuff Healing

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00198185
• Other study ID #: 24087
• Status: Withdrawn
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 2, 2018
• Start date: January 2005
• Est. completion date: January 2005

Study information

• Verified date: January 2018
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff
• Tendon Injuries

Intervention

Procedure:
• Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Musculoskeletal Transplant Foundation

Country where clinical trial is conducted

United States, 

References & Publications (17)

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

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Maffulli N, Moller HD, Evans CH. Tendon healing: can it be optimised? Br J Sports Med. 2002 Oct;36(5):315-6. — View Citation

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. — View Citation

Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. Review. — View Citation

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. — View Citation

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. — View Citation

Weiler A, Förster 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	L'Insalata: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
Primary	American Shoulder and Elbow Surgery (ASES) Patient Survey: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
Secondary	Ultrasound (power Doppler imaging): 6 weeks, 3 months post-operatively
Secondary	Manual muscle testing using a dynamometer: preoperatively, 3 months post-operatively, 6 months post-operatively
Secondary	ASES Physician Survey: preoperatively, 3 months post-operatively, 12 months post-operatively