A device for zone-II flexor tendon repair. Surgical technique.

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 leinert 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 non-compliant with the rehabilitation protocol.

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

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.

Strength analysis and comparison of the Teno Fix Tendon Repair System with the two-strand modified Kessler repair in the Achilles tendon.

BACKGROUND: Various options exist for repair of Achilles tendon ruptures, yet a method that consistently provides sufficient gap resistance to allow early mobilization remains elusive. This study compares the mechanical performance of a modified Kessler repair with that of the Teno Fix Tendon Repair System (Ortheon Medical, LLC) in matched pairs of cadaver Achilles tendons. METHODS: The two-strand modified Kessler repair was selected as the control construct on the basis of literature review and physician interviews which identified it among the many options as a popular method for repair of acutely ruptured Achilles tendons. Test specimens were harvested from matched pairs of cadaver ankles. The tendons were transected 3.5 cm proximal to the calcaneal insertion and repaired with either the two-strand modified Kessler suture construct or the Teno Fix Tendon Repair System. Assignment to the modified Kessler or Teno Fix group was done randomly for the first member of each pair. All test and control repairs were performed by the same author to reduce variability. Evaluation of the repairs consisted of tensile strength testing and measurement of the gap formation and peak stresses. RESULTS: Gap and peak stress for the two-strand modified Kessler repair were 0.30 +/- 0.15 N/mm2 and 1.03 +/- 0.51 N/mm2, respectively. For the Teno Fix repairs the mean gap and peak stress values were 0.80 +/- 0.46 N/mm2 and 1.19 +/- 0.12 N/mm2, respectively. The mean gap formation stress was significantly higher in the Teno Fix repairs than in the control repairs (p < .0005). There was no significant difference in peak strength between the repairs (p < .10). CONCLUSIONS: The Teno Fix repair was superior to the modified Kessler repair. In the Teno Fix repairs, the gap formation stress was 67% of the peak tensile stress. In comparison, in the modified Kessler repairs, the gap formation stress was 29% of the peak stress. This can be correlated to the elastic property of the modified Kessler suture and the initial tightening of the suture around the tendon fibers. The Teno Fix system is nonelastic and is fully tensioned during installation. This lends to a more gap resistant repair.

The efficacy of silver nitrate cauterization for pyogenic granuloma of the hand.

PURPOSE: We report a series of pyogenic granulomas of the hand treated effectively in the office with silver nitrate cauterization. METHODS: Twelve patients with 13 pyogenic granulomas of the hand were treated. The average duration of symptoms was 2 months. Masses were removed bluntly, pressure was held proximal to the lesion to effect hemostasis, and the base of the lesion was cauterized with silver nitrate applicators. After treatment patients were instructed to keep the lesions absolutely dry for 2 weeks. RESULTS: Complete resolution of the pyogenic granuloma was achieved in 85% of patients after an average of 1.6 treatments (range, 1-3 treatments). CONCLUSIONS: Pyogenic granuloma of the hand can be treated simply and effectively with silver nitrate cauterization in the office setting.