Improving Intramedullary Nailing of Proximal Femoral Fractures Through a Navigation Assisted Technique: a Double Blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- TAD (tip to apex) index at the post-operative X-Ray control prior discharge
研究概览
简要总结
The ADAPT system is a software that calculate a virtual 3D reconstruction of the femoral head without additional radiation. It automatically detects the used implant and its position relative to the femoral head, helping the surgeon to achieve an optimal proximal screw positioning in the femoral head. The investigators want to verify if with the addition of the ADAPT system the investigators can improve screw placement and reduce surgery time and radiation exposure.
详细描述
This study is a 2-arm randomized controlled trial comparing intramedullary nailing of proximal fracture of the femur (AO classified as 31 A1.3 , 31 A2.1, 31 A2.2 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3) performed with the ADAPT system (arm-A) and those performed without (arm-B).
The ADAPT system has been developed with the aim to reduce the rate of complications in intramedullary nailing and its usefulness has been previously explored only in two underpowered randomized controlled trials. Thanks to the possibility to track screw placement in real-time, allowing improved screw placement, the ADAPT system could be a valid tool, in order to minimize radiation exposure, surgical time, and rate of complications.
All the patients undergoing intramedullary nailing at the Ospedale Regionale di Lugano satisfying the eligibility criteria reported at section 7.1 will be enrolled in the study and randomly allocated (allocation ratio 1:1) to receive preoperatively:
- Intramedullary nailing with ADAPT system (arm-A)
- Intramedullary nailing without ADAPT system (arm-B) Patients and physicians evaluating the results will be blinded to the assigned group.
The total number of patients enrolled will be 96 (48 arm-A, 48 arm-B). After surgery, data about duration of the procedure, intraoperative blood loss, satisfaction of the surgeon and radiation exposure time will be collected.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral primary intramedullary nailing at the Ospedale Regionale di Lugano.
- •Patients aged 50-85 years old.
- •Patients with a BMI >18 and <
- •Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
- •Radiological evidence of proximal fracture of the femur, AO classified as 31 A1.3, 31 A2.1, 31 A2.2, 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3.
排除标准
- •Other clinically significant concomitant disease states (e.g. renal failure, major hepatic dysfunction, life-threatening cardiovascular disease, etc..).
- •Known or suspected non-compliance, drug or alcohol abuse.
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- •Previous enrolment into the current study.
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
研究组 & 干预措施
Intramedullary nailing without ADAPT system (arm-B)
No aid in performing intramedullary nailing for proximal femoral fractures will be implemented in arm-B
干预措施: Intramedullary nailing without ADAPT system (Procedure)
Intramedullary nailing with ADAPT system (arm-A)
A commercial product, namely ADAPT will be used as investigation product in arm-A
干预措施: Intramedullary nailing with ADAPT system (Procedure)
结局指标
主要结局
TAD (tip to apex) index at the post-operative X-Ray control prior discharge
时间窗: immediately after the surgery
The primary outcome of the study is the TAD (tip to apex) index at the post-operative X-Ray control prior discharge. The TAD is the tip-apex distance, which is the sum of the distance from the tip of the lag screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. The percentage of cut-outs has been correlated directly to both the severity of proximal femoral fractures and the TAD.
次要结局
- time of the procedure(immediately after the surgery)
- non-union(at 6 weeks, 3 months, 6 months and 1-year)
- cut-through rate(at 6 weeks, 3 months, 6 months and 1-year)
- cut-out rate(at 6 weeks, 3 months, 6 months and 1-year)
- intraoperative blood loss(during the surgery)
- surgeon satisfaction on the satisfaction Numerical Rating Scale (NRS scale)(immediately after the surgery)
- intraoperative radiation time(during the surgery)
- VAS(at 6 weeks, 3 months, 6 months and 1-year)
- Oxford Hip Score, [from 0 (severe hip arthritis) to 48 ( satisfactory joint function)](at 6 weeks, 3 months, 6 months and 1-year)
研究者
Christian Candrian
Prof. Dr. Med.
Ente Ospedaliero Cantonale, Bellinzona