Functional Outcomes of Expert Tibial Nailing for Proximal and Distal Tibial Fractures - A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Functional outcome after Expert Tibial Nailing for proximal/distal tibial fractures, assessed using Klemm & Borner functional score and AO radiological criteria
研究概览
简要总结
This is a prospective observational study conducted in the Department of Orthopaedics at Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry. The study aims to evaluate the functional outcome of Expert Tibial Nailing in patients with proximal and distal tibial fractures. Adult patients aged 18 years and above with proximal or distal tibial fractures requiring surgical fixation will be included. Functional outcome will be assessed using Klemm and Borner functional score and AO radiological criteria at regular follow-up intervals. Secondary outcomes will include radiological union, complications, range of motion, and pain scores. The estimated sample size is 33 patients, and the duration of study will be approximately 18 months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with closed or type I open proximal/distal tibial fractures 2.Aged 18 to 70 years.
排除标准
- •1.Pathological fractures 2.Previous surgery to the same limb 3.Associated neurovascular injury 4.Polytrauma or life threatening injuries.
结局指标
主要结局
Functional outcome after Expert Tibial Nailing for proximal/distal tibial fractures, assessed using Klemm & Borner functional score and AO radiological criteria
时间窗: At baseline (pre-operative),3 weeks,6 weeks,3 months and 6 months post-operatively
次要结局
- Demographics and distribution(baseline/throughout follow up)
- Time to Union (radiological)(3 weeks, 6 weeks, 3 months, 6 months)
- Complications(infection,malalignment,implant failure,delayed/non union(3 weeks, 6 weeks, 3 months, 6 months)
- Pain(VAS)(3 weeks, 6 weeks, 3 months, 6 months)
- Knee and Ankle ROM(3 weeks, 6 weeks, 3 months, 6 months)
研究者
SIDDARTH
Sri Venkateshwaraa Medical College Hospital and Research Centre