Peripheral nerve mutilation through biodegradable conduit small gap tubulisation: a multicentre randomised trial

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• 作者：Prof Peixun Zhang ; PhD^a ; Xiaofeng Yin ; PhD^a ; Yuhui Kou ; PhD^a ; Na Han ; PhD^a ; Prof Tianbing Wang ; MD^a ; Prof Guanglei Tian ; MD^b ; Prof Laijin Lu ; MD^c ; Prof Baoguo Jiang ; MD^a ; ^{jiangbaoguo@vip.sina.com" class="auth_mail" title="E-mail the corresponding author}
• 刊名：The Lancet
• 出版年：2015
• 出版时间：October 2015
• 年：2015
• 卷：386
• 期：supp_S1
• 页码：S40
• 全文大小：63 K

文摘

Although peripheral nerve injury is repaired by ingenious epineurial neurorrhaphy, functional recovery is usually not satisfactory and is hindered by many factors, including the misconnections of sensory and motor nerve fibres, difficulties in target organ reinnervation, and painful neuromas. Promoting the effective docking of different fibres and target organ reinnervation remains challenging. The aim of this study was to investigate the possibility of using a biodegradable conduit small gap tubulisation to substitute the traditional epineurial neurorrhaphy for peripheral nerve mutilation. Considering convenience and timesaving, if the clinical regeneration effect of conduit small gap tubulisation were better than traditional epineurial neurorrhaphy, the biodegradable conduit small gap tubulisation to substitute traditional epineurial neurorrhaphy for peripheral nerve mutilation might be an innovation in the peripheral nerve injury and repair specialty.

Methods

This multicentre, randomised clinical trial was done in Peking University People's Hospital, Beijing Jishuitan Hospital, and Jilin University First Hospital between Nov 11, 2008, and Feb 28, 2010. We used a random number method to randomly assign participants to the conduit small gap tubulisation group or epineurial neurorrhaphy group. During the clinical trial process, the participants, investigators and those assessing the clinical outcomes were masked to group assignment, and only the surgeons were not masked. Participants of this study were patients with upper extremities peripheral nerve mutilation. Eligible patients were adults who had traumatic upper extremities peripheral nerve mutilation. The exclusion criteria included heart, lung, liver, kidney malfunction; acute and chronic infection; pathological mutilation; and other contraindication which can not tolerate operation. Patients were randomly assigned tointo two groups by random number method, with Informed consent was obtained from all participants. We assessed the nerve regeneration functional recovery by clinical examination at 1 month, 2 months, 4 months, 6 months, and 5 years after first operation. The mean suture time during operation, the occurrence of painful neuroma rate, and the overall functional assessment were calculated and compared with the control group. The outcome of the two groups was compared using t test statistical methods. The clinical trial protocol was approved by the Institutional Review Boards of Chinese National Drug Administration and the Scientific Ethics Committees of each hospital. This clinical trial is registered with Chinese Clinical Trial Registry Center, number ChiCTR-TNRC-10000801.

Findings

25 cases of peripheral nerve mutilation were repaired by epineurial neurorrhaphy and 25 cases repaired by conduit small gap tubulisation. The mean suture time of conduit small gap tubulisation was 8·33 min (SD 1·59), 20% faster than that of epineural neurorrhaphy (10·71 min (2·89); t=3·608; p<0·0001). The occurrence of painful neuroma rate was lower in the conduit small gap tubulisation group than in the epineural neurorrhaphy group (3% in the conduit small gap tubulisation group vs 45% in the epineural neurorrhaphy group after 2 months [χ²=10·965; p=0·001]; none vs 29% after 4 months [χ²=8<140; p=0·004]; none vs 24% after 6 months [χ²=6<818; p=0·009]; and none vs 17% after 5 years [χ²=4·348; p=0<037). The overall functional assessment at 4 months, 6 months, and 5 years was 18·93%, 36·19%, and 52·00% higher in the conduit small gap tubulisation group than in the control group, respectively.

Interpretation

The 2 mm gap allows for fibers selective regeneration, preventing the escape of ruptured regenerating fibers and reducing painful neuroma occurrence. Biodegradable conduit 2 mm small gap tubulisation can be used to repair peripheral nerve mutilation, thereby replacing the less effective traditional epineurial neurorrhaphy. The outcome of this multiple centers clinical trial may need clinical practice confirmtion.

Funding

Chinese National Ministry of Science and Technology 973 Project Planning (No. 2014CB542206) and 863 Project Planning (SS2015AA020501), The Ministry of Education Innovation team (IRT1201), the National Natural Science Fund (31271284, 31171150, 81171146, 31471144, 30971526), the Educational Ministry New Century Excellent Talents Support Project (No. BMU20110270).