Randomized Controlled Trial of InterTAN Nail Versus Conventional Proximal Femoral Nail: Comparative Analysis of Functional and Radiological Outcomes in Intertrochanteric Femur Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
This study is a single center randomized controlled trial conducted in the Department of Orthopaedics at All India Institute of Medical Sciences Guwahati. The study aims to compare the functional and radiological outcomes of InterTAN nail versus conventional proximal femoral nail in the surgical management of intertrochanteric femur fractures.
Patients aged more than 18 years with clinico radiological diagnosis of intertrochanteric femur fracture will be included after obtaining written informed consent. Patients with open fractures pathological fractures multiple fractures previous surgery in the same limb or cognitive disorders will be excluded. Eligible patients will be randomized into two groups using computer generated random allocation. One group will undergo fixation with InterTAN nail and the other group will be treated with conventional proximal femoral nail.
All surgeries will be performed under standard aseptic precautions by experienced orthopaedic surgeons. Postoperative management will be similar in both groups including antibiotics thromboprophylaxis and early mobilization. Patients will be followed up at two weeks three months and six months after surgery.
The primary outcome will be functional outcome assessed using the Harris Hip Score at six months postoperatively. Secondary outcomes will include radiological assessment of fracture union and neck shaft angle and evaluation of perioperative and postoperative complications such as screw cut out, varus collapse and implant related complications. The results of this study will help determine the comparative effectiveness and safety of InterTAN nail and conventional proximal femoral nail in intertrochanteric femur fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinico-radiological diagnosis of intertrochanteric femur fracture..
- •Age more than eighteen years.
排除标准
- •Open fractures.
- •Pathological fractures.
- •Multiple fractures.
- •History of previous surgery in the lower limb.
- •Patients with cognitive disorders.
研究者
Dr Bidyut Jyoti Bora
AIIMS Guwahati, Assam, India
