Scientific assessment on the outcome of clinical application with peripheral nerve graft materials

Abstract

Objective To discuss how to assess scientifically on the outcome of clinical application with peripheral nerve graft materials. Methods All Pubmed database from 1990 to 2010 were retrieved,and searched the English literatures about the application with peripheral nerve graft materials. The literatures consisted of original clinical research and review excluding animal experiments, repetitive research and irrelevant literatures. The clinical trials data of U.S. was also our target. The information about the safety and effectiveness of peripheral nerve graft materials and related statistical problems were discussed. Results Totally 1578 literatures were identified. Following reading titles and abstracts, we excluded some irrelevant articles. Finally 31 literatures and 2 issue of clinical research from clinical trial data of U.S. were included. After analysis on the literatures, we gained the following results: a remarkable degree of homogeneity among patients can be formed by setting the inclusion and exclusion criteria. For the assessment of proper digital nerve repair, Macknnon- Dellon evaluation is commonly applied, but for the composite nerve, BMRC evaluation is the main method and electromyography can be used as a secondary choice. The safety of peripheral nerve graft materials cannot be evaluated throughout one's life according to the current level of science and technology. It should be evaluated by long-term clinical observation. Randomized clinical trials with random grouping was a gold standard for clinical trials with a good balance and strong comparability. However, non-randomized controlled trials also have an important value. Conclusion It is impossible to make all affected factors homogeneity in a limited timespace conditions of clinical trial. However, we can try our best to keep factors homogeneity to maximum degree by setting the inclusion and exclusion criteria. The scientific assessment of outcome of peripheral nerve repair can be carried out with reasonable and internationally recognized nerve function evaluation methods, strict follow-up time and statistics programme meeting the clinical requirement. Key words: Peripheral nerve; Graft materials; Nerve function evaluation; Literatures assessment