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临床试验/NCT01714999
NCT01714999Unknown不适用

A Prospective Evaluation of the Current Treatment Regime for Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa

Ludwig-Maximilians - University of Munich4 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
4
主要终点
Wound infection

研究概览

简要总结

Following a recent publication by the authors [1], there is no standardized treatment regime for the treatment of lacerations of the olecranon or prepatellar bursa, although primary bursectomy seems to be the most common treatment regime in Germany, Austria and Switzerland. The aim of this study is to prospectively follow patients who suffered from an acute traumatic laceration of the OB or PB treated, according to the local standards, either by bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).

[1] Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)

详细描述

A fall onto the elbow or knee often results in a laceration of the olecranon (OB) and prepatellar bursa (PB), due to their exposed and superficial location. Although a common injury, the authors are not aware of any study dealing with this entity. In order to get a first idea on the treatment concepts currently used, the authors conducted a international online survey among orthopaedic and trauma surgeons in Germany, Austria and Switzerland [1]. The primary treatment approach of more than 70% of Austrian and German surgeons was bursectomy and immobilization, which was performed by less than 50% of Swiss physicians.

At the Departments of Trauma Surgery of the Medical University of Vienna and of the Medical University of Munich, two opposing treatment concepts are being practised. Whereas in Vienna a bursectomy is performed in case of traumatic laceration of the OB and PB, a primary bursal reconstruction is performed at the Medical University of Munich.

The aim of this study is to prospectively follow patients who suffered from an acute traumatic laceration of the OB or PB treated, according to the local standards, either by bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).

The Hypothesis of this study is, that there is no difference with respect to complications between bursectomy and bursal reconstruction in case of acute traumatic laceration of the OB and PB.

  1. Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)

研究设计

研究类型
Interventional
分配方式
Non 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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Acute lacerations of the OB or PB (<12h)
  • Age 18 - 60 years
  • Patient can read and understand German

排除标准

  • Immunodeficient patients
  • Severe dementia
  • Chronic alcoholism
  • Conditions affecting the neuromuscular- or musculoskeletal system
  • Previous surgical interventions at the same joint
  • Conditions affecting wound healing (including chronic alcoholism, insulin dependent diabetes
  • Neurological diseases
  • Patient is not available for follow-up visits
  • Patient suspected to be non-compliant
  • No major concomitant injuries

结局指标

主要结局

Wound infection

时间窗: 6 weeks

次要结局

  • Bursitis(12 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastian. F. Baumbach

M.D.

Ludwig-Maximilians - University of Munich

研究点 (4)

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