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临床试验/NCT02839057
NCT02839057已完成不适用

Survival After Surgical Treatment of Axis Fractures in Elderly: A National Registry Based Cohort Study

Uppsala University0 个研究点目标入组 6,231 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,231
主要终点
Survival

研究概览

简要总结

Fractures of the second cervical vertebra (C2) are the most common spinal fracture among the elderly. Non-surgical treatment comprises of cervical collar treatment for 12 weeks, while surgical treatment for elderly could mean posterior fixation C1-C2 without collar treatment or anterior screw osteosynthesis C2 with 6 weeks of collar treatment. A meta-analysis of retrospective studies has recently found an improved survival with surgical treatment. This national registry study is designed to estimate the survival of non-surgical and surgical treatment in a population-based cohort.

详细描述

The Swedish National Patient Registry (NPR) is hosted by the Swedish Agency of Health and Welfare and contains all patient contacts within Sweden with a coverage of >90% for orthopaedic diagnoses. Registered are main diagnosis and co-morbidity using the ICD-9 code until 1996 and from 1997 onward ICD-10 codes. Treatment is coded since 1996 using the Swedish classification of surgical procedures. Furthermore, information on hospitalisation time is available from the registry.

In the Swedish Cause of Death Registry (CDR) all deaths in Sweden are registered with date of death and cause of death. While date of death coverage is complete, the cause of death has only 46% agreement with the final hospital diagnosis.

All patients with the main diagnosis of C2 fracture (ICD-10: S12.1) treated between January 1st 1996 to December 31st 2014 are extracted from the NPR and merged with the CDR for incident deaths. Prior to data transmission, the Swedish Agency of Health and Welfare anonymised the individual personal identification numbers using a key which remained with the Agency.

Invalid age data will be excluded either due to missing entries or mismatch with date of death. Multiple admissions (cases with same identification number but more than 12 months between admissions) and duplicate entries (cases with same identification number) will be removed from the dataset, after valuable co-morbidity data from the duplicate entries were stored in the original record. Duplicate entries originate from separate recordings from each hospital if the patient is referred to a specialised hospital. Furthermore, primarily non-surgically treated cases with a change of treatment modality are registered as surgical patients. The registered hospitalisation time for these patients is the combined non-surgical and surgical in-hospital treatment period.

From each record the Charlson Comorbidity Index (CCI) is calculated. Using Swedish surgical procedure codes for spinal fusion ("NAG") and spinal osteosynthesis ("NAJ") patients receiving surgical treatment were marked, and the cohort divided into two groups receiving non-surgical or surgical treatment.

研究设计

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

入排标准

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

入选标准

  • C2-fracture
  • Age ≥70 years

排除标准

  • no C2-fracture
  • Age <70 years

结局指标

主要结局

Survival

时间窗: Censored observational time (20 years)

Survival as registered in Swedish National Cause of Death Registry

次要结局

未报告次要终点

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

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