A Prospective Randomized Multicentre Clinical Trial Comparing Open Reduction Internal Fixation With Primary Subtalar Fusion in Patients With Severely Comminuted (Sanders IV), Displaced, Intra-articular Fractures of the Calcaneus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 7
- 主要终点
- General Health Survey - SF-36
研究概览
简要总结
A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres across Canada. It will compare patients who receive open reduction, internal fixation for Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same type of fracture. Patients will be followed up for a period of two years from the time of operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Sanders IV displaced intra-articular calcaneal fracture
- •males and females aged 16-59 inclusive
- •ability to provide informed consent
- •available for follow-up for at least 2 years after injury
排除标准
- •medical contraindications to surgery
- •previous calcaneal pathology (infection, tumor, etc)
- •co-existent foot or ipsilateral lower limb injury
- •open calcaneal fracture
- •injury greater than 3 weeks old
- •head injured patients
- •inability to obtain pre-operative CT scan or accurately classify the fractures according to the Sanders classification system
- •inability to comply with advice to diminish smoking after the injury
- •metal allergy
- •extremely comminuted intra-articular fractures of the calcaneus deemed impossible to reconstruct by the treating surgeon
- •any concerns either by the treating surgeon or patient about harvesting autograft needed for fusion
研究组 & 干预措施
Fix
Open reduction internal fixation of severely comminuted calcaneal fracture (Sanders IV)
干预措施: Open reduction internal fixation (Procedure)
Fuse
Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV).
干预措施: Fusion (Procedure)
结局指标
主要结局
General Health Survey - SF-36
时间窗: 6 months, 12 months, and 24 months
次要结局
- Validated Visual Analogue Scale(6 months, 12 months, and 24 months)
- Musculoskeletal Function Assessment(6 months, 12 months, and 24 months)
研究者
Richard Buckley
Clinical Professor, Section of Orthopaedics, Department of Surgery
University of Calgary