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临床试验/NCT06615999
NCT06615999已完成不适用

Treatment Reality of Tension Band Wiring and Locked Plate Fixation of the Olecranon - Analysis of Complications, Risk Profiles and Trends

University Hospital Muenster0 个研究点目标入组 15,705 人开始时间: 2011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
15,705
主要终点
Revision

研究概览

简要总结

The incidence of the olecranon fracture (OF) in adults is around 12 per 100,000 inhabitants per year.1 The anatomical shape of the proximal ulna is largely responsible for the stabilization of the humeroulnar joint and reconstruction is therefore obligatory, but often challenging. Surgical treatment of the olecranon fracture is performed using tension band wiring (TBW) or locking plate fixation (LPF) osteosynthesis. It is not yet clear, which procedure is superior for a specific patient. In future, an individualized and objectified assessment of expected general and fracture-specific complications should enable the treatment to be individually adapted to the patient's risk profile. This shall prevent complications, unnecessary treatments, and treatment costs. In the project presented here, the reality of care for surgically treated patients with olecranon fractures will be analyzed using routine data collected by the BARMER health insurance fund.

The aim of the study is to analyze differences in the outcome of patients with an olecranon fracture treated with TBW compared to LPF and to identify independent risk factors for unfavorable course.

研究设计

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

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

  • Inpatient coded diagnosis of olecranon fracture (ICD S52.01)

排除标准

  • Incomplete basic information
  • Incomplete insurance status within two years before index
  • Previous treatment of olecranon fracture
  • Unclear treatment of olecranon fracture
  • Age < 18 years
  • Coded polytrauma
  • Bone tumors/ bone metastasis
  • Both sides injured or missing information of surgery side

结局指标

主要结局

Revision

时间窗: up to 5 years

Time from surgery to revision defined above.

Implant removal (only)

时间窗: up to 5 years

* Time from surgery to implant removal * Within first 3 months after surgery, an implant removal will also considered as a surgical complication * No SC is allowed to occur within 3 months and on the same day

Surgical complications (surgical complications)

时间窗: up to 5 years

Time from surgery of olecranon fracture to surgical complications, with death being considered as a competing risk event.

In-hospital surgical complication rate (IH-SC)

时间窗: through hospital stay, an average of 10 days

surgical complication after surgery during index hospitalization (yes/no)

In-hospital implant-associated complications (IH-IAC)

时间窗: through hospital stay, an average of 10 days

In-hospital implant-associated complications after surgery during index hospitalization

In-hospital non-implant associated complications (IH-non-IAC)

时间窗: through hospital stay, an average of 10 days

Non-in-hospital implant-associated complications after surgery during index hospitalizationi

次要结局

  • Overall survival (OS)(up to 5 years)
  • 30-day mortality(30 days)
  • Major adverse events (MAE)(up to 5 years)
  • Thromboembolic events(up to five years)
  • Minor outpatient complication(up to five years)
  • Length of hospital stay during index(an average of 10 days)
  • Charges during index(an average of 10 days)

研究者

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

Prof. Dr. med. J. Christoph Katthagen

Senior Consultant

University Hospital Muenster

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