A Prospective, Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Fusion grade at 12 month follow-up using CT scans
研究概览
简要总结
The purpose of this clinical study is to evaluate fusion of the facet joints in a prospective cohort of patients utilizing the VerteLoc facet fixation device in patients receiving lumbar laminectomy (L1-S1), without ancillary stabilization devices such as pedicle and transfacet screws.
详细描述
Study Design: Non-randomized, prospective, single arm clinical trial
Patient Population and Sample Size: Patients (n=25) from up to 2 clinical site, who have been medically evaluated, found appropriate for, and have agreed to treatment by lumbar decompressive laminectomy and facet fixation, including unilateral and/or bilateral posterolateral fusion according to accepted medical standards.
Objectives:
The primary objective of this study is to:
- Evaluate the fusion status of facet joints following laminectomy and facet fixation using the VerteLoc system in combination with unilateral and/or bilateral posterolateral fusion.
- Subject success / Clinical outcome: Evaluate the reduction in baseline VAS back pain score at 2-3 weeks, 3 months, and 12 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have provided consent for research by signing the Institutional Review Board approved Informed Consent;
- •Have given appropriate operative consent for a decompressive lumbar (L1-S1) laminectomy procedure as standard of care;
- •Are skeletally mature, and are at least 18 years of age;
- •If female, are not pregnant;
- •Agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation.
排除标准
- •Previous surgery at the target or adjacent vertebral levels;
- •More than two intervertebral levels to be treated by the laminectomy procedure;
- •Found to be inappropriate candidates for facet fixation using the VerteLoc system;
- •Require additional and/or other surgical technique and/or approach to the laminectomy at the index level(s), which may in the opinion of the Primary Investigator confound measurement of outcome variables;
- •Has a medical disorder or is receiving medications that would be expected to interfere with osteogeneses,
- •Active malignancy or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years of surgery;
- •Active local or systemic infection or history of local or systemic infection, immune-deficiency, uncontrolled medical conditions, which in the opinion of the Investigator may increase patient risk or confound fusion results;
- •BMI >40% ;
- •History of tobacco smoking within the past 6 months;
- •Has a history of alcoholism, medication or drug abuse, psychosis, is a prisoner, and/or has a personality disorder, poor motivation, emotional or intellectual issues that would likely make the patient unreliable for participation in the study;
- •Are participating in any other clinical trial.
结局指标
主要结局
Fusion grade at 12 month follow-up using CT scans
时间窗: 12 months
Fusion grade at 12 month follow-up using CT scans with a grading system based on: 1. Complete fusion; 2. Partial fusion; 3. No fusion;
次要结局
- Subject success / Clinical outcome(2-3 weeks, 3 months and 12 months)