A comparative analysis of the outcome of various reconstruction options in complex ankle defects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- To study the outcomes of various reconstructive options for complex ankle defects.
研究概览
简要总结
Lower extremity damage management is one of the disciplines of reconstructive surgery that has emerged significantly over time. Foot and ankle are responsible for ambulation and for the posture of human body. There is a lack of local soft tissue, blood supply and the long bones are subcutaneous which makes them exposed, even in small sized defects. This poses challenging problems for surgeons in cases of lower extremity trauma.
It is a Randomized controlled trial comparing the outcomes of free flap and locoregional flap reconstruction in complex ankle defects. It also includes studying the impact of various pre-operative factors and complications on long term outcomes.
It includes patients with complex ankle defects with paucity of local soft tissue. The primary aim is to compare the aesthetic, functional and psychosocial outcomes of free flap and locoregional flap reconstruction in complex ankle defects. It also includes studying the impact of various pre-operative factors and complications on long term outcomes. All patients will be asked to sign written informed consent forms. Patients will be divided into two groups A and B by the SNOSE method of randomization. Group A patients will undergo free flap reconstruction and group B will undergo locoregional reconstruction. Concealment and blinding is not applicable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with complex ankle defects with paucity of local soft tissue.
排除标准
- •1 Patients who previously underwent locoregional/free flap for same or any other indication, which precludes both free and locoregional flap.
- •2 Patients with loss of sensation of foot 3 Pediatric age group (5 years and below).
结局指标
主要结局
To study the outcomes of various reconstructive options for complex ankle defects.
时间窗: to assess the outcomes at immediate, at 2 weeks, 1 month, 3-month intervals postoperatively
次要结局
- to study the aesthetic outcome of various reconstructive options for complex ankle defect(to assess the outcomes at 3-month interval postoperatively)
- To assess the functional outcome of various reconstructive option(will be assessed after the patient is ambulatory/ bony union)
- To assess the psychosocial outcomes of various reconstructive options for complex ankle defects(assessed after the completion of ambulation/ 3 months whichever is earliest)
- To assess the impact of various pre operative factors & complications on long term outcomes(assessed on 3 month, 6 month /last follow up in postoperative period)
研究者
Dr Sanjana S I
All India Institute of Medical Sciences , Jodhpur