Intramedullary Nailing Versus Plates for Femoral Shaft Fractures in Dar es Salaam, Tanzania With Minimum 1-Year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Reoperation
研究概览
简要总结
This is a prospective observational study of patients with femur fractures in Dar es Salaam, Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open reduction internal fixation (ORIF) with a plate. The primary outcome is the rate of reoperation for any reason, and the secondary outcomes are fracture healing, return to work, and health-related quality-of-life. The investigators hypothesize that there will be a difference in the rate of reoperation for patients with femur fractures treated with an IMN compared to ORIF with a plate.
详细描述
The study will be a prospective clinical trial conducted at Muhimbili Orthopaedic Institute (MOI) in Dar es Salaam, Tanzania. All adult patients with diaphyseal femur fractures meeting the eligibility criteria will be invited to enroll. Study subjects will be treated at the discretion of the surgeons at MOI. This could include an intramedullary nail, a plate, external fixation, or skeletal traction. Potential confounders recorded will be age, gender, body mass index, comorbidities, fracture pattern, open versus closed injury, time from injury to presentation, time from presentation to surgery, and associated injuries. The primary outcome considered will be reoperation for any reason. Secondary outcomes will be clinical union, defined as full-painless weight bearing on the injured extremity, radiographic union, return to work, and health-related quality-of-life. Follow up will be scheduled at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery and will include both clinical and radiographic evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diaphyseal fracture amenable to operative fixation with an intramedullary nail or plate
- •Age 18 to 65
排除标准
- •Clinical evidence of infection at the surgical site (defined clinically as drainage or erythema)
- •Pathologic fracture
- •Prior surgery
- •Presentation 3 weeks or more after injury
- •Inability or unwillingness to comply with follow up to 1-year
结局指标
主要结局
Reoperation
时间窗: 1-year
Reoperation involving the affected femur for any reason within the first year will be considered an event.
次要结局
- Clinical union(1-year)
- Health-related quality of life(1-year)
- Return to work(1-year)
- Radiographic Union(1-year)