Prospective Comparison of Open Reduction Internal Fixation of Calcaneus Fractures With and Without Tricortical Iliac Crest Bone Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Union and healing of Calcaneus Fracture
研究概览
简要总结
The purpose of this study is to compare patient functional outcomes for surgical fixation of calcaneus fractures with and without tricortical iliac crest bone grafting
详细描述
This study was designed as a randomized, prospective evaluation of patients who have sustained an intra-articular calcaneus fracture that requires open reduction with internal fixation as the preferred method of treatment. Patients who desire to participate in this study will be randomized into one of two groups. Group A will be made up of patients that undergo open reduction with internal fixation and Tricortical iliac crest bone grafting. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting. All other surgical techniques and management of the fracture and patient will remain unchanged.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •intra-articular calcaneus fractures requiring open reduction and internal fixation
- •Adult patient (19 years or older)
- •Mental capacity to comply with post-operative regimen, evaluation and data collection
排除标准
- •non-operative fractures for primary or secondary reasons
- •prior surgery to the hindfoot of the involved lower extremity
- •inability to comply with post-operative regimen, evaluation and data collection
- •inability or unwillingness to give informed consent
结局指标
主要结局
Union and healing of Calcaneus Fracture
时间窗: 3 month to 12 month healing period
次要结局
未报告次要终点