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临床试验/NCT05683314
NCT05683314招募中不适用

A Comparison Study for Unstable Sacrum/Pelvis and Acetabular Fracture Treated With Open Reduction and Internal Fixation With Minimally Invasive Internal Fixation

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
EQ-VAS

研究概览

简要总结

Unstable sacral/pelvic or acetabular fracture are severe high energy fractures Surgical intervention are necessary after patient's conditions are stable. The complexity of local anatomical structure, the nearby major vessels, organ and visceral structures make the operations difficult and in high risks.

详细描述

The surgical principles are concluded as:

  1. Sacrum fracture with rotational instability: close reduction and iliosacral screw fixation
  2. Sacrum fracture with vertical shearing instability: open reduction and ipsilateral riangular osteosynthesis with /without neurological decompression
  3. Spinopelvic dissociation: open reduction and bilateral triangular osteosynthesis with

/without neurological decompression 4. Iliac fracture with sacroiliac joint(SI) joint dislocation: close reduction with iliosacral screw fixation (for SI joint dislocation), anterior open reduction with double plates fixation (for iliac fracture) 5. Anterior acetabular/ pubic fracture: close /open reduction with plates/screw fixation. 6. Symphysis dislocation: open reduction with double plates 7. Acetabulum fracture: posterior open reduction with double plates anterior open /minimally invasive reduction with plates/screw fixation. The implementation of anterior column screw under C-arm X-ray transillumination for pubic fractures was first report in the literature in 1995, and we had this surgical method in our hospital since 2011. The first report of minimally invasive internal fixation in pelvic or acetabular in the literature was reported in 2013, and we had such minimally invasive surgical approach in our hospital since 2014. We would like to retrospectively and prospectively collect the final outcome of these patients and the comparative analysis of different surgical methods in our institution.

AO foundation published an updated fracture and dislocation classification compendium in 2018. Pelvic ring fracture is classified into ABC three type according to intact, incomplete/complete disruption of the posterior arch. Each type of injury is further divided into groups regarding of severity. The old Young Burgess classification of pelvic ring injury has been integrated into this classification. This retrospective study aim to re-classify patients who sustained unstable pelvic fracture and underwent surgery in CMUH under Dr. Tsai since 2009 according to the new system.

The investigators adopted Majeed Pelvic Score for functional outcome and EQ-5D for quality of life evaluation. A telephone survey will be conducted for all patients. Multiple logistic and linear regression analyses will be used for statistical assessment with the MPS and the EQ-5D. This will provide the investigators with the insight of the correlation between injury severity and functional/QOL outcome. Also, the investigators' study aims to determine the prognostic factors relate to poor outcome. Age, mechanism of injury, sex, ISS score, associated injury, surgical method, bladder or neurologic complication, radiologic outcome,unity of fracture will be recorded from medical chart. Statistical analysis will be conducted to identify the correlation between each factor that influence the functional and QOL outcome.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 18 years old and above with the appropriate informed consent
  • traumatic pelvic or acetabular fracture with 2018 AO/OTA classification
  • a minimum of 48 months postoperative follow-ups

排除标准

  • pelvic or acetabular fractures that were pathological or non-traumatic in nature
  • patients with incomplete follow-up details
  • patients who denied surgical management
  • patients who received external fixation as part of their treatment strategy

结局指标

主要结局

EQ-VAS

时间窗: Post-operative at 48th month

The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

EQ-5D

时间窗: Post-operative at 48th month

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used.

Majeed pelvic score

时间窗: Post-operative at 48th month

he Majeed scoring system is a disease-specific outcome measure that was originally designed to assess pelvic injuries.

次要结局

  • Blood loss(intraoperative blood loss)
  • Surgical duration(intraoperative duration)

研究者

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

Chun-Hao Tsai

Medical doctors, Department of Orthopedics , Principal Investigator, Clinical Professor

China Medical University Hospital

研究点 (1)

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