Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Change in the Majeed pelvic score
研究概览
简要总结
the main aim of this study is to evaluate the results of performing minimally invasive surgical management for cases with traumatic spinopelvic instability and spinopelvic dissociation. This will include using percutaneous pedicle and S2 alar iliac screws, minimally invasive transforaminal lumbar interbody fusion and transtubular posterior decompression.
详细描述
Study Procedure:
- Patient enrollment and pre-operative evaluation:
Upon Arrival, the patient will be managed in the emergency department according to the Advanced Trauma Life Support (ATLS) protocol. After achieving the haemodynamic stability, in cases of shock, X-rays (AP and lateral view of the lumbosacral region, inlet and outlet views of the pelvis) and CT scan of the pelvis will be performed. If the fracture pattern fits the inclusion criteria, the patient will be offered to enroll in the study and the patient will be prepared for surgery. 2. Surgery:
The surgery will be performed under general anaesthesia and fluoroscopic guidance. The patients will be positioned prone on an open top of a radiolucent table with large bumps under the thighs to accentuate an extension force on the legs which will be the main reduction maneuver in the surgical procedure.
Bilateral percutaneous L4 and L5 pedicle screws will be placed under fluoroscopic guidance with Jamshidi needles, and these were will also be used the iliac fixation via percutaneous S2 alar iliac screws.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature patients presenting with sacral fractures (provided that the fracture line passes below the level of S2) associated with lumbosacral instability showing one of the following:
- •Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2)
- •Spinopelvic dissociation (AO type C3)
- •Traumatic lumbosacral dislocation
排除标准
- •unwillingness to participate in the study
- •pathological fractures
- •other medical comorbidities that preclude surgical intervention.
结局指标
主要结局
Change in the Majeed pelvic score
时间窗: it will be assessed at one and half month, three month, six month and one year after the surgery
it is a patient reported outcome score used for functional assessment after pelvic fractures.The score ranges from 0 to 100 with 0 representing the most disability and 100 the best function.
次要结局
- Short Form 12 (SF-12) score(it will be assessed at one and half month, three month, six month and one year after the surgery)
- sacral kyphosis angle(it will be assessed at one and half month, three month, six month and one year after the surgery)
- Oswestry disability index (ODI):(it will be assessed at one and half month, three month, six month and one year after the surgery)
- Visual analogue scale of pain (VAS)(it will be assessed at one and half month, three month, six month and one year after the surgery)
- lumbar lordosis(it will be assessed at one and half month, three month, six month and one year after the surgery)
- pelvic incidence(it will be assessed at one and half month, three month, six month and one year after the surgery)
- sacral table angle(it will be assessed at one and half month, three month, six month and one year after the surgery)
- Gibbons' criteria(it will be assessed at one and half month, three month, six month and one year after the surgery)
- AO PROST(it will be assessed at one and half month, three month, six month and one year after the surgery)
- AP translation(it will be assessed at one and half month, three month, six month and one year after the surgery)
- vertical translation(it will be assessed at one and half month, three month, six month and one year after the surgery)
研究者
Ahmed Abdelazim Abdelrahim Hassan
Assistant Lecturer of Orthopedics and Trauma Surgery
Assiut University