Results of the Staged Surgical Approach for Management of Infected Un-united Femoral Shaft Fractures in Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Change in the patient-reported clinical outcome as assessed using the WOMAC Osteoarthritis Index from enrollment to 1-year follow-up after the definitive stage.
研究概览
简要总结
Assessment of the efficacy of the multistage technique in the eradication of infection and achieving the union of traumatic infected femoral un-united shaft fractures in adult patients for one year follow up.
详细描述
All cases will be treated by the induced membrane technique in two stages. In the first stage, thorough debridement of the infected bone and soft tissues and copious lavage will be done.
After radical debridement, primary fixation will be done by either external fixation or antibiotic cement coated internally fixed implants.If there is a bone defect, it will be measured and filled with an antibiotic-impregnated (PMMA) cement spacer. The second stage procedure will be performed 4 to 8 weeks after the first one if soft tissue permits and only if there is no clinical or biochemical evidence of ongoing infection as indicated by normal white blood cell count, C-reactive protein, and erythrocyte sedimentation rate. It includes the exchange of the antibiotic cement spacer by a cancellous bone graft.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age between 18 and 65 years old.
- •Type 32 according to Arbeitsgemeinschaft für Osteosynthesefragen classification in adults.
排除标准
- •Patients with deficient soft tissue coverage with exposed bone.
- •Patients with reflex sympathetic dystrophy.
- •Spinal injuries associated with neurological complications affecting the lower limbs.
- •Associated head injury affecting the conscious level or the motor power of the injured limb.
- •Associated mutilating limb injury or peripheral amputation.
- •Bone defect more than 6 cm in length.
- •Chronic peripheral ischemia of the limb.
- •Past history of pathological fractures.
结局指标
主要结局
Change in the patient-reported clinical outcome as assessed using the WOMAC Osteoarthritis Index from enrollment to 1-year follow-up after the definitive stage.
时间窗: from enrollment to one year follow up after the definitive stage.
WOMAC is composed of 24 items over 3 subscales (5 for pain, 2 for stiffness, and 17 for physical function). Participants can rate their difficulty for each item.
次要结局
未报告次要终点
研究者
Michael Girgis Waheeb Tawfeek
Orthopaedic Surgeon
Assiut University