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临床试验/NCT06481865
NCT06481865招募中不适用

Weight-bearing of Patients After Pelvic Ring Fracture: A Monocentric Observational Study

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
Evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing

研究概览

简要总结

Pelvic ring fractures are fractures associated with high morbidity and mortality. When the fracture is displaced, surgical management to achieve reduction and fixation of the anterior and posterior annulus is the current reference. The optimal technique that gives the best results is controversial. Open reductions and internal fixations (ORIFs) are associated with more blood loss and a higher rate of infection, while closed reductions and percutaneous fixations (CRPF) are associated with more screw misplacements and thus vascular or nerve damage. The results appear to be similar in the literature between the two approaches

Surgery for pelvic ring fractures has become increasingly common over the past three decades Recovery is often delayed for weeks post-surgery, depending on the center. Modern management emphasizes early rehabilitation, including early mobility and weight-bearing, when possible. Increasing the number of screws, their diameter and length, and systematically fixing both anterior and posterior lesions add safety for early reloading

The aim of the study is The main objective of the study is to evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture in a large cohort of patients at Grenoble University Hospital, compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing.

The investigator hypothesize that early weight-bearing of pelvic ring fractures with biomechanically stable fixation does not result in significant differences in clinical outcomes at a minimum of one year compared to patients with delayed weight-bearing

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient at the time of injury
  • Pelvic ring fracture
  • Pre-operative X-rays
  • Pre-operative CT scan
  • Post-operative X-rays
  • Postoperative CT scan
  • Willingness and ability to participate in the study.

排除标准

  • Ipsi-lateral fracture of the femoral and/or associated acetabulum (Floating Hip C or B)
  • Pregnant and breastfeeding women
  • People under guardianship, protected adults

结局指标

主要结局

Evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing

时间窗: 1 year

Clinical outcomes according to functional assessment ( Majeed score)

次要结局

  • Define the prognostic factors associated with poor clinical outcomes and Pseudoarthrosis or vicious callus.(1 year)
  • Compare clinical outcomes and radiological results with the literature(1 year)
  • Evaluation of the outcomes and complications of immediate weight-bearing in elderly patients.(1 year)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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Weight-bearing of Patients After Pelvic Ring Fracture | 临床试验