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临床试验/NCT04370561
NCT04370561已完成不适用

a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates

Technical University of Munich0 个研究点目标入组 45 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
主要终点
Ankle function

研究概览

简要总结

In this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). In Group II early weight bearing was allowed after two weeks postoperatively. Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score (OMAS), Foot and Ankle outcome score (FAOS) and Karlsson and Peterson Scoring System for Ankle function (KPSS). Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 65 years
  • Fracture of the distal fibula (AO 44 B1.1, B1.2, B1.3)
  • Written informed consent

排除标准

  • Pregnancy
  • mental disorders
  • comprehensive legal support.
  • pathological and/or osteoporotic fracture
  • open fracture

结局指标

主要结局

Ankle function

时间窗: 12 month

Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)

次要结局

  • Ankle function(12 month)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Chlodwig Kirchhoff

Clinical Professor

Technical University of Munich

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