The Journal of bone and joint surgery. American volume
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J Bone Joint Surg Am · May 2005
Randomized Controlled Trial Multicenter Study Clinical TrialDevice for zone-II flexor tendon repair. A multicenter, randomized, blinded, clinical trial.
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. ⋯ 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.