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Renerve® 合成胶原神经导管治疗指神经损伤的中期疗效:回顾性单中心研究。

Mid-term outcomes of digital nerve injuries treated with Renerve® synthetic collagen nerve conduits: A retrospective single-center study.

机构信息

Trauma and Microsurgery Center, Toyohashi Municipal Hospital, Toyohashi, Japan; Hand and Reconstructive Unit, Department of Orthopedics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.

Department of Hand Surgery, Nagoya University Hospital, Nagoya, Japan.

出版信息

J Orthop Sci. 2024 May;29(3):809-816. doi: 10.1016/j.jos.2023.04.004. Epub 2023 May 4.

Abstract

BACKGROUND

Biodegradable synthetic nerve conduits have become widely used for peripheral nerve injuries. Recently, bioabsorbable collagen conduits filled with collagen fibers (Renerve®) are commercially available in Japan. We investigated the clinical efficacy and safety of Renerve® conduits for digital nerve repair.

PATIENTS AND METHODS

We retrospectively reviewed data of patients who underwent digital nerve repair using Renerve® conduits between August 2017 and February 2022 at our hospital and were followed up for at least 12 months. Seventeen patients (20 nerves) with a median age of 46.5 years (interquartile rage: 26-48 years) were included in the analysis. We analyzed sensory nerve function recovery and residual pain or uncomfortable tingling, as well as safety outcomes. The relationship between nerve defect length and sensory function data was assessed using Spearman's rank correlation.

RESULTS

Sensory nerve function at 12 months postoperatively was excellent in six, good in 10, and poor in four nerves, and that at the final follow-up (median period, 24 months; range, 12-30 months) was excellent in nine, good in 10, and poor in one nerve. All nerves with a defect length of <12 mm had excellent or good sensory outcomes. At 12 months postoperatively, the correlation coefficients between nerve defect length and Semmes-Weinstein monofilament test results, static two-point discrimination, and dynamic two-point discrimination were 0.35 (p = 0.131), 0.397 (p = 0.0827), and 0.451 (p = 0.0461), respectively. Residual pain or tingling sensation were observed in four nerves at the final follow-up. No postoperative complications were observed in any of the patients.

CONCLUSIONS

This study demonstrated the clinical efficacy and safety of Renerve® conduits for digital nerve repair. Our results will be useful in clinical practice because of the scarcity of real-world data on the use of Renerve® conduits for digital nerve repair.

摘要

背景

可生物降解的合成神经导管已广泛应用于周围神经损伤。最近,在日本市售一种填充胶原纤维的可吸收胶原导管(Renerve®)。我们研究了 Renerve®导管修复指神经的临床疗效和安全性。

患者和方法

我们回顾性分析了 2017 年 8 月至 2022 年 2 月在我院接受 Renerve®导管修复的患者数据,这些患者至少随访 12 个月。分析纳入 17 例(20 条神经)患者,中位年龄 46.5 岁(四分位间距:26-48 岁)。分析感觉神经功能恢复情况,以及残留疼痛或不适的刺痛感,并评估安全性结局。采用 Spearman 秩相关分析评估神经缺损长度与感觉功能数据之间的关系。

结果

术后 12 个月时,6 条神经感觉功能为优,10 条为良,4 条为差;末次随访(中位时间 24 个月;范围 12-30 个月)时,9 条为优,10 条为良,1 条为差。所有缺损长度<12mm 的神经感觉功能均为优或良。术后 12 个月,神经缺损长度与 Semmes-Weinstein 单丝试验结果、静态两点辨别觉和动态两点辨别觉的相关系数分别为 0.35(p=0.131)、0.397(p=0.0827)和 0.451(p=0.0461)。末次随访时,4 条神经仍有残留疼痛或刺痛感。所有患者均未出现术后并发症。

结论

本研究表明 Renerve®导管修复指神经具有临床疗效和安全性。由于 Renerve®导管修复指神经的真实世界数据较少,因此本研究结果在临床实践中具有一定参考价值。

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