Intramedullary Nailing Versus External Ring Fixation for Surgical Treatment of Tibial Shaft Fractures in Adults and Their One Year Outcome on Recovery: Study Protocol for a Pragmatic Randomized Controlled Trial (The IMVEX Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 3
- 主要终点
- The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)
研究概览
简要总结
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures.
详细描述
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures.
The primary aim of the project is to compare the one-year Knee Injury and Osteoarthritis Outcome Score - Sport (KOOS-Sport) after standard intramedullary nailing with external ring fixation for patients with tibial shaft fractures.
The explorative aim is to report the effect of the two surgical procedures on the development of complications, time to bone union, pain reactions, muscle strength, activity of daily living and time to return to work.
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 (Outcomes Assessor)
盲法说明
Due to the nature of the study participants, care providers and investigator can not be blinded. The outcome assessor will be blinded with regards to the two treatment groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fracture of the tibial shaft
- •OTA classification Type: 42-A1-A3, -B1-B3 and -C1-C3
- •The fracture type is deemed operable by intramedullary nail
排除标准
- •Below 18 years of age
- •Open fracture
- •History of severe systemic diseases or cancer
- •Bilateral tibial shaft fracture
- •Multi fracture patients
- •Pregnancy
- •Patients without gait function prior to fracture
研究组 & 干预措施
Intramedullary Nail
Intramedullary Nailing: Alignment will be obtained by closed or limited open reduction of the fracture. A standard reamed intramedullary nail is inserted. Access above the patella, through the patella tendon or parapatellar access is used according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. Patients are administered preoperative antibiotics (Dicloxacillin) 15 minutes before surgery commences. Postoperative antibiotics is administered by discretion of the surgeon based on individual patient considerations.
干预措施: Intramedullary Nailing (Procedure)
External Ring fixator
External Ring fixation: Closed or limited open reduction of the fracture is performed. A circular frame is attached on both sides of the fracture. Connection to the bone is obtained by hydroxyapatite coated half pins and/or k-wires with olives as needed according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. After applying the ring fixator alignment is assessed radiologically and corrected both peri- and postoperatively. Patients are administered preoperative antibiotics (Dicloxacillin) preoperatively 15 minutes before surgery commences. Following surgery antibiotics are continued until wounds, pin- and wire perforations are dry.
干预措施: External Ring fixation (Procedure)
结局指标
主要结局
The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)
时间窗: 12 month follow up
KOOS-sport is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems with regards to activity. The subscale sport is one five subscales: pain, ADL, symptoms, sport and QOL in the KOOS questionnaire . A total score of 100 indicates no symptoms, and 0 indicates major symptoms.
次要结局
- Patient Acceptable Symptom State (PASS)(3+6+12 months)
- Patient-reported pain reactions(6 weeks, 3+6+12 months)
- Pain sensitivity(6 weeks, 3+6+12 months)
- Radiological alignment(6 weeks, 3+6+12 months)
- Health related QOL(6 weeks, 3+6+12 months)
- Health economic evaluation(12 months)
- Perceived Pain(6 weeks, 3+6+12 months)
- Gait assessment(3+6+12 months)
- Muscle strength(6+12 months)
- Time to bone union(6 weeks, 3+6+12 months)
- The Knee Injury and Osteoarthritis Outcome Score (KOOS)(6 weeks, 3+6+12 months)
- Time to return to work(6 weeks, 3+6+12 months)
- Foot And Ankle Outcome Score (FAOS)(6 weeks, 3+6+12 months)
研究者
Rasmus Elsøe
Head of Orthopaedic trauma
Aalborg University Hospital