Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 9
- 主要终点
- Fracture Healing
研究概览
简要总结
Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of intramedullary nails for the fixation of long bone fractures. This study is designed to compare the union rates between fractures reamed by standard reaming versus reaming with a Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based outcomes on these patients. Little information exists on the patient based outcomes following femur fractures. We hope that the patient based outcomes of this study will also be able to aid physicians in advising patients with femur fractures of their possible outcomes.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women between the ages of 18 years and 85 years;
- •Acute fractures of the femoral shaft
排除标准
- •Fractures not amenable to intramedullary nailing and deemed by the treating surgeon;
- •Pathological fractures;
- •Open fractures;
- •Patients with additional injuries to the ipsilateral femur;
- •Surgical delay of greater than 7 days from the time of injury;
- •Retained hardware in the affected limb;
- •Previous infection in fractured limb;
- •Likely problems in the judgment of the investigators with maintaining follow-up;
- •Patients with severe cognitive injuries or disabilities will be excluded if it is deemed that they will be unable to complete the study questionnaires;
- •Hopeless diagnosis;
- •Medical comorbidities that prohibit the conductance of surgical treatment under a general anesthetic;
- •Fractures requiring cephalomedullary nails
研究组 & 干预措施
1
Standard Reaming of femoral shaft fracture prior to intramedullary nailing
干预措施: Standard Reaming (Procedure)
2
Reamer/Irrigator/Aspirating of femoral shaft fracture prior to intramedullary nailing
干预措施: Reaming/Irrigating/Aspirating (Procedure)
结局指标
主要结局
Fracture Healing
时间窗: 3 months, 6 months, 1 year, 2 years
次要结局
- Patient Based Quality of Life(Baseline, 3 months, 6 months, 1 year, 2 years)