VariLift Lumbar and Cervical Patient Registry
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
- 3
- 主要终点
- Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50
研究概览
简要总结
The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and improved patient care. All patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the VariLift device. Potential treatment procedures include bilateral posterior lumbar interbody fusion (PLIF), unilateral transforaminal lumbar interbody fusion (TLIF), or bilateral anterior lumbar interbody fusion (ALIF) for the lumbar spine, or cervical unilateral or bilateral ACDF procedure. Surgical procedures can be performed in either an inpatient or outpatient facility. It is anticipated that the VariLift devices will improve patient outcomes and lead to the development of treatment pathways to improve patient care.
详细描述
The registry is design to collect data prospectively on patients undergoing spinal fusion using the VariLift-L, VariLift-A, or VariLift-C device patients will be enrolled in the registry after reviewing the protocol with their health care provider and signing the informed consent. Data will be collected at recommended time points based on the standards of care of the participating sites. The registry will serve as a database in which retrospective analysis and exploratory analysis of specific research questions will be answered.
Follow up visits will be defined by the treating physicians based on their standard practice. Typical clinical follow up schedules for patients undergoing this type of surgery are pre-operative and 12 months post-operative.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient is undergoing a procedure with unilateral or bilateral placement of VariLift
- •This is the first surgery at the index level
- •Patient has understood and signed the informed consent
- •Patient is skeletally mature
排除标准
- •Revision Surgery
- •Is a Worker's Compensation Case
- •Infection at the operative site
- •Sustained trauma with instability
- •Sustained fracture of the vertebra at any of the lumbar spinal levels
- •Has a primary diagnosis of degenerative or isthmic spondylolisthesis greater than Grade 1
- •Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or drug abuse)
- •Has a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the clinical study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy, metastasis to vertebrae, adult onset diabetes, active rheumatoid arthritis, etc.)
- •Is an immunologically suppressed or receiving steroid in excess of usual doses
- •Is obese (as defined by a Body Mass Index (BMI) of > 40 kg/m2 (BMI equals (weight in pounds x 703) / (height in inches x height in inches))
- •Has disabling and daily narcotic dependency greater than 18 months
- •Has a known malignancy
- •Has a known allergy to metal implants
结局指标
主要结局
Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50
时间窗: Pre-operative and Post-operative 12 months post-operative
ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability \>34 Complete disability
Change in VAS Pain
时间窗: Pre-operative and Post-operative 12 months
VAS Pain comparison Preoperative vs post-operative of greater than or equal to 6. VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means 'no pain' and a ten (10) means 'worst imaginable pain'
次要结局
- Radiological Assessment(Post-operative follow up)