Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 9
- 主要终点
- Examine the influence of reduction quality on the primary functional outcome (as assessed using the Foot and Ankle Ability Measure (FAAM)) of patients with pilon fractures treated with plate fixation.
研究概览
简要总结
This prospective case series will essentially examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation.
The plates used in this trial can be chosen according to the preferences of the surgeon.
详细描述
A prospective case series to examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation. Radiological parameters including single/combined alignment and various articular measurements will also be validated according to their reliability. The sensitivity of the effects of reduction quality on functional outcome, and an extended evaluation of patient-rated functional and social outcomes as well as their outcome expectations will also be assessed as part of the secondary study aims.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Patients with a unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 - B1, B2 and B3 (partial intraarticular) AO 43 - C1, C2 and C3 (total intraarticular)
- •Definitive fracture fixation with a plate within 4 weeks after accident (Temporary fixation with an external fixator, cast or traction is allowed)
- •Signed written informed consent (by the patients) and agreement to attend the planned FU evaluations
排除标准
- •Contralateral fracture of the distal half of the tibia/fibula/talus
- •Pathologic fracture
- •Severe Polytrauma: Injury Severity Score (ISS) > 28
- •Preexisting severe vascular disease (chronic venous insufficiency, chronic arterial occlusive disease)
- •Drug or alcohol abuse
- •American Society of Anesthesiologists (ASA) class V and VI
- •Inability to walk independently prior to injury event
- •Neurological and psychiatric disorders that would preclude reliable assessment
结局指标
主要结局
Examine the influence of reduction quality on the primary functional outcome (as assessed using the Foot and Ankle Ability Measure (FAAM)) of patients with pilon fractures treated with plate fixation.
时间窗: 2 years
The most important predictors of functional outcome after pilon fracture will be identified by evaluating the influence of radiologically assessed parameters of reduction quality and other factors (age, high/low energy trauma, AO fracture type, open/closed fracture, delay between trauma and definitive fracture fixation) on the FAAM. In parallel, the radiological parameters will also be validated with respect to their reliability.
次要结局
- Surgical details(1 year)
- Pre- and postoperative treatment(1 year)
- To assess whether patient and surgeon expectations are met with regard to the trauma outcome(1 year)