经皮钳固定治疗胫腓骨不稳定型骨折的多中心临床观察与疗效评价

目的 客观评价模拟中医正骨手法设计的经皮钳固定治疗胫腓骨不稳定型骨折的临床疗效、安全性及规范技术操作。方法 为前瞻性、标准对照的多中心临床试验。观察对象为200例符合纳入标准的胫腓骨不稳定型骨折患者，试验分为治疗组和对照组。治疗组采用经皮钳固定治疗，对照组采用单侧多功能外固定支架治疗。结果 两组固定操作时问，治疗后1周末、去除固定器具后临床总计分及临床愈合时间及远期综合疗效评价比较，治疗组优于对照组。经CMHχ^2检验，考虑中心效应后，临床总疗效比较，差异仍有显著性（P〈0．01）。安全性评估两组比较，经CMHχ^2检验，差异有显著性（P〈0．01）。结论 本方法为胫腓骨不稳定型骨折提供了新的简便、可靠的治疗方法，具有临床应用与推广价值。

Multicentre Study on Treatment of Unstable Tibiofibular Fracture with Percutem Clamp Therapy

Objective To objectively evaluate the clinical efficacy, safety and technical operating standard of percutem clamp fixation (PCCF), an operation designed by imitating bone setting method of TCM, in treating unstable tibiofibular fracture (UTF). Methods A prospective controlled multicentrc clinical study was carried out on 200 patients with UTF, they were assigned to the treated group (99 cases) treated with PCCF and the control group (101 cases) treated with unilateral multifunctional external fixator (UMFEF). Results PCCF showed better effects than UMFEF in reducing the time of fixing operation and healing time; and the immediate effect after removing the fixating apparatus and long-term efficacy as well as safety in the treated group were also superior to those in the control group (P<0.01). Conclusion It is convenient, safe and effective to treat UTF by fixation with percutem clamp.