Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 10
- 主要终点
- Anterior Knee Pain
研究概览
简要总结
Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith& Nephew's Trigen META intramedullary nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee flexion) and Group B=with the semi-extended surgical technique. (2*100 patients)
Research Objectives:
The primary research objectives are to evaluate:
i) anterior knee pain and ii) the nail position and overall fracture alignment
Outcome Measures:
- Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.
- Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires
- Knee-related adverse events
- Overall fracture alignment
详细描述
After surgery with standard intramedullary nailing technique in tibia fractures, 40-80% of the patients still complain of anterior knee pain postoperative. The expected advantages of the semi-extended nailing technique is less anterior knee pain and less malunion of the fracture.
Using the semi-extended nailing technique also might give the advantage of better position of the nail by a more concentric reaming of the tibia, due to less tension on the patella tendon during reaming process.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has sustained a closed (Tscherne Classification) or open tibial fracture (Gustillo-Anderson Classification) that is amendable for operative fixation with an intramedullary nail.
- •Patient has an isolated tibia and fibula fracture
- •Skeletally mature
- •Patients aged between/including 18 to 70 years
- •Patient has given formal consent to be involved in the trial and has completed the study consent form
- •Patient is likely to comply with study follow-up requirements
排除标准
- •Pathologic fractures
- •Other fractures involving the same lower extremity
- •Soft tissue injuries/problems that would prevent the surgeon from using both of the surgical techniques to insert an intramedullary nail
- •Patient having pre-existing knee joint disease causing anterior knee pain
- •Patient likely to have problems with follow-up
- •Patient unwilling to give informed consent to be included in the trial
结局指标
主要结局
Anterior Knee Pain
时间窗: 4, 6 and 12 months post-operative
Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee)
次要结局
- Nail positioning(Operation (day 1))