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临床试验/NCT04933045
NCT04933045Unknown不适用

Treatment of Syndesmotic Disruption With Anatomic Distal Tibiofibular Ligament Augmentation

St. Clair Orthopaedics1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
1
主要终点
Indications and outcomes of operative fixation of syndesmotic injuries

研究概览

简要总结

The primary objective is to evaluate indications and outcomes of operative fixation of syndesmotic injuries, at least in part, with direct anatomic augmentation in acute and subacute traumatic cases. The secondary objective of the study is to evaluate clinically the InternalBraceTm to facilitate the direct syndesmotic fixation/augmentation.

详细描述

A syndesmosis is a slightly movable fibrous joint in which bones such as the tibia and fibula are joined together by connnective tissue. Together, they form a bracket shaped socket, covered in hyaline cartilage. This socket is known as the mortise. A syndesmotic or 'high 'ankle sprain is when the ligaments binding the distal tibia and fibula at the ankle joint are injured or torn. This can lead to the ankle joint and syndesmoses to being malaligned, subluxed or widened. Subsequently, this can lead to ankle arthritis and deformity with persistent pain and swelling about the ankle.

There are no generally accepted treatment guidelines. Thus, there still remains considerable controversies regarding diagnosis, classification and treatment of syndesmotic injuries. Syndesmotic malreduction is the most common indication for early re-operation after ankle fracture surgery, and widening of the ankle mortise by only 1 mm decreases the contact area of the tibiotalar joint by 42%. Outcome of ankle fractures with syndesmosis injury is worse than without, even after surgical syndesmotic stabilization. This may be due to a high incidence of syndesmotic malreduction revealed by increasing postoperative computed tomography controls. Therefore, even open visualization of the syndesmosis during the reduction maneuver has been recommended. Thus, the most important clinical predictor of outcome is consistently reported as accuracy of anatomic reduction of the injured syndesmosis. In 2017 a new syndesmotic InternalBraceTM technique for improved anatomic distal tibiofibular ligament augmentation to protect healing of the injured native ligaments was introduced. This technique involves direct surgical inspection of the syndesmoses for injury and subsequent augmentation.

This study hopes to evaluate the results of this direct syndesmotic augmentation/stabilization to help determine if this is perhaps a safer, and possibly more effective method.

This prospective study is designed to evaluate 32 consecutive patients that did have an acute or subacute syndesmotic injury that necessitated surgical stabilization and used at least in part the InternalBrace technique. There was not a restriction of age, gender, or race.

2 patients who were labeled as having severe syndesmotic disruption and had additional screw fixation. Also, 5 patients had dynamic syndesmotic fixation in addition to direct InternalBrace augmentation of the AITFL.

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 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Skeletally mature patients that occurred an ankle syndesmotic injury necessitating surgical stabilization/fixation

排除标准

  • Skeletally immature patients, patients with nonoperatively managed ankle injuries

结局指标

主要结局

Indications and outcomes of operative fixation of syndesmotic injuries

时间窗: 1 year

Evaluate indicatinos and outcomes of operative fixation of syndesmotic injuries at least in part with direct anatomic augmentation in acute and subacute traumatic ankle fracture cases.

次要结局

  • InternalBrace(1 yeaer)

研究者

发起方
St. Clair Orthopaedics
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher N Zingas

Orthopedic Surgeon

St. Clair Orthopaedics

研究点 (1)

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