Prospective, Observational Study of Anterior Bridging Cage Augmented With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- InCBB of Both Cages
研究概览
简要总结
The purpose of this study is to evaluation for the pattern of bone bridging of patients who undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior to auto local bone only. In addition, the investigators will analyze anterior new bone bridging pattern between anterior bridging cage newly developed and grafted bone in anterior disc space.
详细描述
A single center, observational, single arm study to evaluate the efficacy of auto local bone mixed with β-calcium phosphate + hydroxyapatite using interbody fusion assessment on multi-axial CT scan. Its active comparator is auto local bone.
Anterior bridging bone between anterior grafted bone and inserted cage will be assessed by using newly developed anterior bridging cage as well as interbody bone bridging between two vertebral bodies on multi-axial reconstructed CT scan.
The patients undergoes arthrodesis surgery will have two cages, one augmented with auto local bone will be located at left side of disc space and the other cage augmented with auto local bone mixed with β-calcium phosphate + hydroxyapatite at right side of disc space.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who need lumbar interbody fusion in Degenerative spine disease on L1-S1(Spinal stenosis, HIVD and internal derangement of disk, spine instability)
- •Patients who have no communication problems
- •Patients who are willing to visit the hospital for any follow-up assessment
- •Patients who voluntarily sign on a written consent
排除标准
- •Patients who have infection
- •Patients who have bleeding disorders
- •Patients who have immunosuppressed disease
- •Patients who can't sign on consent form
- •Patients who are in pregnancy or breast feeding
- •Patients who have severe osteoporosis
- •Patients who can't take general surgery because of severe liver disease or decreased renal function
- •Patients who have acute spinal injury, spinal tumor or inflammatory spinal disease
结局指标
主要结局
InCBB of Both Cages
时间窗: 12 month postoperatively
We used the concept of InCBB (intra-cage bridging bone) to evaluate the fusion status. InCBB was defined as the bridging bone between the upper and lower vertebrae through the void of the cage(s) and divided into right (Rt.) and left (Lt.) InCBB according to the cage position. We graded bridging scores from 0 to 2 based on the degree of completion of the bridging bone in InCBBs (grade 0: no bridging at the superior and inferior endplates; grade 1: incomplete bridging; bridging at the superior or inferior endplate, but with a clear radiolucent line; grade 2: complete bridging).
次要结局
- ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone(12 month postoperatively)
研究者
Kwang Sup Song
Professor
Zenoss Co, Ltd