Masaomi Saeki1, Kenji Tanaka2, Junya Imatani3, Hideki Okamoto4, Kentaro Watanabe5, Toshiyasu Nakamura6, Hiroyuki Gotani7, Hiroyuki Ohi8, Ryogo Nakamura9, Hitoshi Hirata10. 1. Department of Hand Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: saeki.masaomi@c.mbox.nagoya-u.ac.jp. 2. Hand and Microsurgery Center, Anjo Kosei Hospital, Anjo, Japan. 3. Department of Orthopaedic Surgery, Okayama Saiseikai General Hospital, Okayama, Japan. 4. Department of Orthopaedic Surgery, Nagoya City University Medical School, Nagoya, Japan. 5. Department of Orthopaedic Surgery, Nagoya Ekisaikai Hospital, Nagoya, Japan. 6. Department of Orthopaedic Surgery, School of Medicine, Keio University, Tokyo, Japan. 7. Department of Orthopaedic Hand and Microsurgery Center, Seikeikai Hospital, Osaka, Japan. 8. Hand and Microsurgery Center, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan. 9. Nagoya Hand Surgery Center, Chunichi Hospital, Nagoya, Japan. 10. Department of Hand Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Abstract
INTRODUCTION: The safety and efficacy of using artificial collagen nerve conduits filled with collagen filaments to treat nerve defects has not been fully studied in humans. We conducted a multicenter, controlled, open-label study to compare the safety and efficacy of artificial nerve conduit grafts with those of autologous nerve grafts. METHODS: We included patients with a sensory nerve defect of ≤30 mm, at the level of the wrist or a more distal location, with the first-line surgical methods selected according to a patient's preference. We compared sensory recovery using static two-point discrimination and adverse events between the artificial collagen nerve conduit and autologous nerve grafting. RESULTS: The artificial nerve conduit group included 49 patients, with a mean age of 42 years and nerve defect of 12.6 mm. The autologous nerve graft group included 7 patients, with historical data of an additional 31 patients, with a mean age of 36 years and nerve defect of 18.7 mm. The rate of recovery of sensory function at 12 months was 75% (36/49) for the artificial nerve conduit group and 73.7% (28/38) in the autologous nerve group. No serious adverse events directly associated with use of the artificial nerve conduit were identified. CONCLUSIONS: The treatment of nerve defects ≤30 mm using artificial collagen nerve conduits was not inferior to treatment using autologous nerve grafts. Based on our data, the new artificial collagen nerve conduit can provide an alternative to autologous nerve for the treatment of peripheral nerve defects.
INTRODUCTION: The safety and efficacy of using artificial collagen nerve conduits filled with collagen filaments to treat nerve defects has not been fully studied in humans. We conducted a multicenter, controlled, open-label study to compare the safety and efficacy of artificial nerve conduit grafts with those of autologous nerve grafts. METHODS: We included patients with a sensory nerve defect of ≤30 mm, at the level of the wrist or a more distal location, with the first-line surgical methods selected according to a patient's preference. We compared sensory recovery using static two-point discrimination and adverse events between the artificial collagen nerve conduit and autologous nerve grafting. RESULTS: The artificial nerve conduit group included 49 patients, with a mean age of 42 years and nerve defect of 12.6 mm. The autologous nerve graft group included 7 patients, with historical data of an additional 31 patients, with a mean age of 36 years and nerve defect of 18.7 mm. The rate of recovery of sensory function at 12 months was 75% (36/49) for the artificial nerve conduit group and 73.7% (28/38) in the autologous nerve group. No serious adverse events directly associated with use of the artificial nerve conduit were identified. CONCLUSIONS: The treatment of nerve defects ≤30 mm using artificial collagen nerve conduits was not inferior to treatment using autologous nerve grafts. Based on our data, the new artificial collagen nerve conduit can provide an alternative to autologous nerve for the treatment of peripheral nerve defects.
Authors: Raluca Ioana Teleanu; Oana Gherasim; Tudor George Gherasim; Valentina Grumezescu; Alexandru Mihai Grumezescu; Daniel Mihai Teleanu Journal: Pharmaceutics Date: 2019-06-08 Impact factor: 6.321