Two-stage Open Reduction and Internal Fixation Versus Single-stage External Fixation for Complex Intra-articular Distal Tibial Fractures : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functional
研究概览
简要总结
This study aims to compare the clinical, radiological, and functional outcomes of two-stage open reduction and internal fixation with single-stage external fixation in the treatment of comminuted tibial pilon fractures.
详细描述
A pilon fracture ( also known as tibial plafond fractures) is a fracture of the distal end of the tibia with comminution, intra-articular extension and significant soft tissue injury.Pilon injury accounts for about 5% to 10% of all tibial fractures, and for <10% of lower extremity injuries. The incidence rate is relatively low. However, with the high incidence of high energy trauma and accidental falls, the number of comminuted fractures has increased in recent years.Among all pilon fractures, about 30% are complex pilon fractures (AO/ OTA 43C type) caused by high-energy injuries.
Most complex pilon fractures are associated with severe soft tissue injuries, making the treatment challenging. Optimal treatment of comminuted pilon fractures requires precise anatomical reduction accompanied by early functional exercise. Several methods have been advocated to manage complex pilon fractures, but an optimal fixation technique remains controversial.
In 1979, Ruedi and Allgower first reported satisfactory results with primary open reduction and internal fixation.However, many authors have noted significant complications when open reduction and internal fixation was applied to severe pilon fractures, including an infection rate as high as 55%, wound necrosis and skin sloughing. These complications arose from the internal fixation, leading many orthopaedic surgeons to choose external fixation as an alternative.
Although external fixation decreased wound necrosis and skin sloughing, high rates of pin site infection and malalignment with subsequent non-union occurred. Therefore, orthopaedic surgeons made great efforts to establish methods that provided good results and decreased postoperative complications.
With the accumulation of surgical experience and the development of surgical techniques, two-stage open reduction and internal fixation and limited internal fixation combined with external fixation were established, and these two methods are now widely advocated for the treatment of comminuted tibial pilon fractures.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Skeletally mature patients
- •Both males and females
- •Closed or open (grade 1&2) pilon fractures according to Gustilo and Anderson classification
- •AO/OTA type C fractures
- •Compromised soft tissue not allowing for primary open reduction and internal fixation
- •Unilateral or bilateral
- •Isolated or polytrauma patients
排除标准
- •Skeletally immature patients
- •Open grade 3 pilon fractures
- •Patients eligible for primary open reduction and internal fixation
- •Ipsilateral lower limb fractures
- •Pathological fractures
- •Pre-existing symptomatic ankle arthritis
结局指标
主要结局
Functional
时间窗: 12 months
Functional outcome will be assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) evaluation system. The score includes I.Pain (40 point) II. Function (50 points) It's divided into 7 items 1. Activity limitations, support requirements (10points) 2. Maximum walking distance, blocks (5 points) 3. Walking surfaces (5 points) 4. Gait abnormality (8 points) 5. Sagittal motion (flexion plus extension) (8points) 6. Hindfoot motion (inversion plus eversion) (6points) 7. Ankle-hindfoot stability (anteroposterior, varus-valgus) (8 points) III. Alignment(10 points) IV. Total Score(100 points)
Radiological
时间窗: 12 months
Accuracy of reduction in plain x Ray using burwell\& charnely score It includes Anatomical reduction , fair reduction \& poor reduction 1. Anatomical... * No medial or lateral displacement of the medial \& lateral malleulus * no angulation * no more than 1 ml of longitudinal displacement of the medial or lateral malleli * no more then 2 ml of proximal displacement of a large posterior fragment * no talus displacement 2. Fair ... * No medial or lateral displacement of the medial \& lateral malleulus * no angulation * 2-5 ml of posterior displacement of lateral malleulus * 2-5 ml of proximal displacement of a large posterior fragment * no talus displacement 3. Poor ... * Any medial or lateral displacement of the medial \& lateral malleulus * no angulation * more than 5 ml of posterior displacement of lateral malleulus * more than 5 ml of proximal displacement of a large posterior fragment * any residual talus displacement
次要结局
未报告次要终点
研究者
Mohamed Osama Mohamed Eissa
principal investigator
Ain Shams University