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临床试验/NCT07028944
NCT07028944Enrolling By Invitation不适用

Prospective Analysis of Medial Clear Space Widening in Weber B Ankle Fractures: A Comparison of Three Methods

University of Utah1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月25日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1
主要终点
Medial Clear Space (MCS) Widening Under Gravity Assisted Stress

研究概览

简要总结

The investigators purpose of this study is to obtain all three standard of care stress views of the ankle (gravity stress, manual stress, weightbearing stress) to compare the amount of tibiotalar joint instability predicted by each to determine if there are significant differences measured by the differing stress techniques.

详细描述

Rotational ankle injuries are a commonly encountered injury. Classification of these injuries is most commonly by the Danis-Weber (or Weber) classification and the Lauge-Hansen classification.

Within this classification system exists the isolated Weber B or Lauge-Hansen Supination External Rotation 2/4 (SER 2/4) injury which radiographically involves an isolated spiral fracture of the lateral malleolus at the level of the tibiofibular syndesmosis.

The difference between SER2 (isolated) Weber B injuries and SER4 injuries is disruption of the medial ankle mortise structures, either the medial malleolus (4a) or deltoid ligaments (4b) which then can permit increased talar subluxation with potential to result in tibitotalar joint incongruity.

Standard practice is to proceed with operative fixation of rotationally unstable Weber B or SER4b injuries.

To determine the competence of medial ligamentous structures in isolated fractures of the fibula at the level of the syndesmosis when there is minimal widening of the mortise on non weight bearing films there are three plain x-ray views currently widely used and considered standard of care:

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a Weber B ankle fracture who are skeletally mature (no open physes) and older than 18 years of age.

排除标准

  • Medial and/or posterior Malleolar fracture
  • Any other lower extremity trauma that limits weight bearing
  • Concomitant arthridities/rheumatologic disease (patients with osteoarthritis may be included)
  • Prior fracture
  • Prior surgery of foot, talus or ankle
  • Open fracture
  • Initial NWB xrays with a medial clear space (MCS) > 7 mm or medial clear space> superior clear space (SCS) by 2mm, signifying an unstable fracture prior to stress
  • Protected populations

结局指标

主要结局

Medial Clear Space (MCS) Widening Under Gravity Assisted Stress

时间窗: Day 1 Clinic Visit

Measured distance, millimeters(mm) of the fractured fibula at the level of the syndesmosis joint in patients undergoing gravity assisted stress

Medial Clear Space (MCS) Widening Under Manual External Rotation Stress

时间窗: Day 1 Clinic Visit

Measured distance, millimeters(mm) of the fractured fibula at the level of the syndesmosis joint in patients undergoing manual external rotation stress

Medial Clear Space (MCS) Widening Under Weight-bearing Stress

时间窗: Day 1 Clinic Visit

Measured distance, millimeters(mm) of the fractured fibula at the level of the syndesmosis joint in patients undergoing weight-bearing stress

次要结局

未报告次要终点

研究者

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

Lucas Marchand

Principle Investigator

University of Utah

研究点 (1)

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