Device for zone-II flexor tendon repair. A multicenter, randomized, blinded, clinical trial.

Overview

abstract

BACKGROUND: The stainless-steel Teno Fix tendon-repair device has improved biomechanical characteristics compared with those of suture repair, and it was well tolerated in a canine model. The purpose of this study was to compare the Teno Fix with suture repair in a clinical setting. 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.