跳至主要内容
临床试验/NCT05325268
NCT05325268已完成不适用

Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Oxford Elbow Score (OES)

研究概览

简要总结

Patients who had suffered a Monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (PROM) after treatment with osteosynthesis.

详细描述

A retrospective, monocentric study will be performed. Patients who underwent surgical treatment after suffering a Monteggia injury or a Monteggia like lesion between 2012 and 2018 will be included. Fractures will classified after Bado and Jupiter, according to the fracture location of the proximal ulna, as well as regarding the potential accompanying ligamentary injury.

In a follow-up examination validated patient-reported outcome measures (Disabilities of Arm, Shoulder and Hand Score [DASH], MEPS [Mayo Elbow Performance Score], Oxford Elbow Score [OES], Pain, Subjective Elbow Score) and functionality (range of motion [ROM], posterolateral instability, strength, valgus-/varus-stress) will be evaluated. In addition, treatment strategy and complications will be analysed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with Monteggia fractures treated with osteosynthesis between 2012 and 2018
  • understanding of German language (written and oral)
  • informed consent

排除标准

  • Patients not meeting the above criteria

结局指标

主要结局

Oxford Elbow Score (OES)

时间窗: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months

Evaluation of the subjective function (patient reported outcome) using the OES-Score, 0 - 48, best: 48, worst: 0

Disabilities of Arm, Shoulder and Hand Score (DASH)

时间窗: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months

Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100

Range of Motion (ROM)

时间窗: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months

Objective functional clinical result. Evaluation of Motion of the Elbow in ° measured via goniometer. Physiological: Flexion/Extension 140/0/0°.

Mayo Elbow Performance Score (MEPS)

时间窗: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months

Evaluation of the subjective function (patient reported outcome) using the MEPS-Score, 0-100, best: 100, worst: 0

次要结局

  • Ulnar fracture localization (Radiologically)(baseline (timepoint of injury))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验