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Device for Zone-II Flexor Tendon Repair

A Multicenter, Randomized, Blinded, Clinical Trial

¹ Department of Orthopaedic Surgery, The Trauma Training Center, New York Presbyterian Hospital, 622 West 168th Street, PH 11, Room 11-64, New York, NY 10032. E-mail address for M.P. Rosenwasser: ttc{at}columbia.edu
² University of Cape Town, Room 128, Vincent Pallotti Hospital, Alexandra Road, Pinelands, Cape Town 7405, South Africa. E-mail address: docsol{at}iafrica.com
³ P.O. Box 902, Wendywood 2144, South Africa. E-mail address: andymels{at}global.co.za
⁴ Nelson R. Mandela School of Medicine, 5 Pfanner Road, Marion Hill Park, Pinetown 3610, South Africa. E-mail address: sened{at}hit.co.za
⁵ Via Usignolo 1, 20147 Milan, Italy
⁶ Hand and Microsurgery Associates, 3400 Olentangy River Road, Suite 200, Columbus, OH 43202
⁷ Department of Orthopaedic Surgery, University of California, San Francisco, 500 Parnassus Avenue, Room MU 320-W, Box 0728, San Francisco, CA 94143-0728. E-mail address:diaoe{at}orthosurg.ucsf.edu
⁸ 415 Church Street, Suite 101, Vienna, VA 22180. E-mail address: matt.quitkin{at}verizon.net

Investigation performed at Columbia University Medical Center, New York, NY, Groote Schuur Hospital, Cape Town, Johannesburg General Hospital, Johannesburg, and King Edward VIII Hospital, Durban, South Africa

A video supplement to this article is available from the Video Journal of Orthopaedics. A video clip is available at the JBJS web site, www.jbjs.org. The Video Journal of Orthopaedics can be contacted at (805) 962-3410, web site: www.vjortho.com.

In support of their research or preparation of this manuscript, one or more of the authors received grants or outside funding from Ortheon Medical, Winter Park, Florida. In addition, one or more of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity (Ortheon Medical). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Methods: Sixty-seven patients with isolated zone-II flexor tendon injury were randomized to be treated with a Teno Fix or a four-stranded cruciate suture repair. There were eighty-five injured digits: thirty-four were treated with the Teno Fix, and fifty-one served as controls. A modified Kleinert rehabilitation technique was employed, with active flexion starting at four weeks postoperatively. Patients were followed for six months by blinded observers who determined the range of motion, Disabilities of the Arm, Shoulder and Hand (DASH) score, pinch and grip strength, and pain score on a verbal scale and assessed swelling and neurologic recovery. Adverse outcomes, including device migration and rupture, were monitored at frequent intervals.

Results: Nine of the fifty-one suture repairs ruptured, whereas none of the Teno Fix repairs ruptured (p < 0.01). Five of the nine ruptures were caused by resistive motion against medical advice. There were no differences between the two groups in terms of range of motion, DASH score, pinch and grip strength, pain, swelling, or neurologic recovery. The Teno Fix group had slightly slower resolution of pain and swelling compared with the control group. Of the patients who were available for follow-up at six months, sixteen of the twenty-four treated with a Teno Fix repair and nineteen of the twenty-seven treated with a control repair had a good or excellent result. One Teno Fix device migrated and extruded secondary to a wound infection. Of all eighty-five digits that were operated on, four were thought to have tendons of inadequate size to accommodate the device and nine were deemed to have inadequate exposure to allow placement of the anchors.

Conclusions: The Teno Fix is safe and effective for flexor tendon repair if the tendon size and exposure are sufficient. Tendon repairs with the Teno Fix have lower rupture rates and similar functional outcomes when compared with conventional repair, particularly in patients who are noncompliant with the rehabilitation protocol.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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A Device for Zone-II Flexor Tendon Repair

Brian W. Su, Michael Solomons, Andrew Barrow, Matshediso E. Senoge, Marco Gilberti, Lawrence Lubbers, Edward Diao, H. Matthew Quitkin, Michael W. Grafe, and Melvin P. Rosenwasser
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				B. W. Su, M. Solomons, A. Barrow, M. E. Senoge, M. Gilberti, L. Lubbers, E. Diao, H. M. Quitkin, M. W. Grafe, and M. P. Rosenwasser A Device for Zone-II Flexor Tendon Repair J. Bone Joint Surg. Am., March 1, 2006; 88(1_suppl_1): 37 - 49. [Abstract] [Full Text] [PDF]

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