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临床试验/NCT03649360
NCT03649360已完成不适用

Knee Pain After Tibial Shaft Fracture Treated With Intramedullary Nailing

Copenhagen University Hospital, Hvidovre1 个研究点 分布在 1 个国家目标入组 223 人开始时间: 2009年11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
223
试验地点
1
主要终点
Knee Pain after Tibial Shaft Fracture Treated with Intramedullary Nailing

研究概览

简要总结

The primary objective of this study is to evaluate the long-term outcome after inserting an intramedullary nail in patients with a tibial shaft fracture using an injury-specific questionnaire.

详细描述

Introduction

The treatment of choice for unstable diaphyseal fractures in the tibia is reamed insertion of an intramedullary nail (IMN) with the additional placement of interlocking screws. The most common complication after insertion of an IMN as treatment of tibial shaft fractures is chronic knee pain with reported rates between 10 % and 87 % with a mean of 47,4 % in metaanalyses.

Methods

The primary objective of this study is to evaluate the long-term outcome after inserting an IMN in patients with a tibial shaft fracture using an injury-specific questionnaire.

This study includes patients operated on five Danish hospitals. A database search was made using operational codes for insertion of an IMN in a five-year period. Patients aged 18 years or older, alive and residing in Denmark at the time of follow-up could be included in the study. These patients then received a Knee Injury and Osteoarthritis Score (KOOS) questionnaire by mail with questions regarding knee-specific symptoms, stiffness, pain, function and quality of life. Questionnaires were filled out and returned to the corresponding physician for further analyze. Patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients aged 18 years or older, alive and residing in Denmark at the time of follow-up could be included in the study.

排除标准

  • Patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.

结局指标

主要结局

Knee Pain after Tibial Shaft Fracture Treated with Intramedullary Nailing

时间窗: 1st of November 2009 till 30th of October 2014.

The primary objective of this study is to evaluate the long-term outcome after inserting an IMN in patients with a tibial shaft fracture using an injury-specific questionnaire. We used the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire to collect patient data. It is used to assess patient's subjective opinion about symptoms related to the knee and other associated problems. The questionnaire has been translated and validated in Danish and consists of 5 subscales: pain, symptoms, function in daily living (ADL) function in sports and recreation and knee-related QOL. Each subscale has between 4 and 17 questions (a total of 42 questions) with each question having 5 options ranging from no symptoms to severe symptoms. Each question gets a score from 0-4 and a score from 0-100 is calculated. 100 indicating no symptoms and 0 indicates major symptoms.

次要结局

未报告次要终点

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikolaj Erin-Madsen

Principal Investigator

Copenhagen University Hospital, Hvidovre

研究点 (1)

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