A Novel Technique for Degenerative Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage Fusion
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Evaluation of fusion status
研究概览
简要总结
● Null hypothesis (H0): Unilateral pedicle screw with contralateral interbody cage has better outcomes than unilateral pedicle screw fixation with ipsilateral cage.
● Alternative hypothesis (H1):
Unilateral pedicle screw with contralateral interbody cage gives the same outcomes as unilateral pedicle screw fixation with ipsilateral cage.
详细描述
Lumber interbody fusion is one of the commonest neurosurgical procedures. A lot of studies showed the value of unilateral approach which resulted in less cost, time and radiation exposure when use interbody cage with ipsilateral pedicular screws fixation in comparison to bilateral approach when use interbody cage with bilateral pedicular screws fixation.
Fusion rate, cage migration, and biomechanical stress were the main draw backs of unilateral approach by lumber interbody fusion with ipsilateral cage and screws. Cage size and location seemingly the main reasons with advice to use large cage and cage insertion in oblique fashion to cross the midline. This study was designed to solve these issues.
Sample size:
The Study will include 40 patients divided into two groups, each group containing 20 patients.
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 (Participant)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient acceptance.
- •Both sexes.
- •Age (21-60) years old.
- •Patients with monosegmental lumber degenerative spinal diseases including lumbar spondylosis, spondylolysis, spondylolisthesis grade one, or lumbar disc prolapse.
排除标准
- •Patient refusal.
- •Altered mental status.
- •Patients with associated comorbidity interfere with surgery.
- •Extremes of age.
- •Multiple level lumbar degenerative disease
- •Spinal tumour
- •Active infection
- •Previous lumbar operation
结局指标
主要结局
Evaluation of fusion status
时间窗: up to 3 months
Evaluation of fusion status using CT scan and Xray
次要结局
- Back Pain(At 24 hours, 2 weeks and 3 months after surgery)
研究者
wael Abdelrahman Elmesallamy
principle investigator
Zagazig University