Prospective Comparative Analysis Evaluating Radiographic and Clinical Outcomes of Stand-Alone Anterior Cervical Discectomy and Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Degree of radiographic fusion
研究概览
简要总结
Study team will plan a prospective, randomized control trial using our institution's spine clinical outcomes registry. Eligible patients undergoing ACDF (see inclusion criteria listed below) will be randomized to an Intervention or Control Group, which will differ according to the interbody cage used during the procedure. In the Intervention Group (100 patients), Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted at each treated level. In the Control Group (100 patients), patients will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology. Interbody cages used in the Control Group (along with the decision to apply anterior plate fixation) will be determined according to surgeon preference. There will be no blinding to the type of implant used. Standard demographic and procedural variables will be collected for all patients (including history of diabetes, tobacco, use, prior use of oral corticosteroids, number of levels fused, and presence of bicortical screw placement). Clinical and radiographic outcomes in the Intervention and Control Groups will be directly compared.
详细描述
Aim 1: Examine the effect of nanoLOCK technology on rates of postoperative dysphagia after ACDF.
Aim 2: Evaluate the effect of nanoLOCK technology on radiographic fusion.
Aim 3: Evaluate how nanoLOCK technology influences the development of radiographic adjacent segment disease.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years of age or older
- •Subjects undergoing ACDF surgery for degenerative pathology (one, two or three levels)
- •Subjects with no prior history of cervical spine surgery
- •Subjects with complete/usable data
排除标准
- •Subjects under the age of 18
- •Subjects not undergoing ACDF surgery
- •Subjects with prior cervical spine surgery
- •Subjects with cervical neoplastic or infectious disease pathology
- •Subjects with cervical trauma pathology
- •ACDF performed at C2-3
- •Subjects with incomplete/unusable data
研究组 & 干预措施
Intervention Group
Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted for participants in this group
干预措施: Titan nanoLOCK interbody cage (Device)
Control Group
Participants in this arm will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology.
干预措施: ACDF interbody cage (Device)
结局指标
主要结局
Degree of radiographic fusion
时间窗: 12 months following surgery
Degree of radiographic fusion is measured by quantifying (count of) the presence of bony trabeculae crossing the interface between the implant and adjacent levels as obtained via CT of the cervical spine.
Number of patient reported dysphagia events measured by Eat-10 assessment tool
时间窗: 12 months following surgery
Number of patient reported dysphagia events (incidence \& severity ) is measured by Eating Assessment Tool (EAT-10) post surgery at day1 which is self-administered, symptom-specific outcome instrument for dysphagia. It consists of ten statements that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem.
Dysphagia as measured by SWAL-QOL assessment tool
时间窗: 12 months following surgery
Dysphagia is measured by SWAL-QOL assessment tool which is designed to find out how one's swallowing problem has been affecting their day-to-day quality of life. Scoring in each domain is calculated by the sums of scores for each item expressed as a percentage of the maximum possible domain score. A total SWAL-QOL score is derived by summing each domain score and dividing by 10 giving a total SWAL-QOL score that ranges between 0 and 100 (worst-best).
Incidence of radiographic adjacent segment disease
时间窗: 12 months following surgery
Incidence of radiographic adjacent segment disease is measured by quantifying (number of occurrence) the following parameters (i.e., Suprajacent and/or subjacent level kyphosis; Vacuum disc phenomenon at adjacent level discs; Adjacent level compression deformity) on postoperative imaging
次要结局
- Number of participants who experienced overall complications(3 years following surgery)
- Percentage of participants experiencing neck pain(12 months following surgery)
- Percentage of participants showing functional improvement(12 months following surgery)
- Percentage of participants reporting functional outcomes as measured by PROMIS-29(12 months following surgery)
研究者
Salah Aoun
ASSISTANT PROFESSOR
University of Texas Southwestern Medical Center