NCT03162666撤回不适用
Post-market Surveillance Study of Altera™ Minimally Invasive Articulating Expandable Spacer in a TLIF Interbody Fusion Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Radiographic Analysis
研究概览
简要总结
This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.
详细描述
The evaluation is based on the following elements.
- Safety as measured by the rate of serious operative and post-operative complications.
- Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline.
- Global and segmental lumbar lordosis (LL)
Patients will be followed upto 24 months post-operative
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (18-70 y/o)
- •Male or Female
- •With the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:
- •Degenerative disc disease with up to Grade I spondylolisthesis
- •Spondylolisthesis
- •Failure of at least 6-months conservative treatment
- •BMI < 40
- •Subject to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one
- •Ability to read, understand, and sign informed consent
排除标准
- •Infection, local to the operative site
- •Signs of local inflammation
- •Fever or leukocytosis
- •Pregnancy
- •Significant mental disorder or condition that could compromise the Subject's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
- •Prior surgical procedure (with the exception of decompression only procedure) at the index level(s) using the desired operative approach
- •Prior fusion procedure at an adjacent level
- •Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count
- •Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care
- •Active local infection in or near the operative region
- •Active systemic infection and/or disease
- •Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation
- •Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)
- •Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs
- •Suspected or documented allergy or intolerance to implant's materials
- •Symptomatic cardiac disease
- •Subject unwilling to cooperate with postoperative instructions.
- •Any case where the implant components selected for use would be too large or too small to achieve a successful result.
- •Subject having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
- •Any Subject in which implant utilization would interfere with anatomical structures or expected physiological performance.
- •Prior fusion at the level to be treated.
- •Back VAS < 4/10
结局指标
主要结局
Change in Radiographic Analysis
时间窗: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
Global and Segmental Lumbar Lordosis in degrees
次要结局
- Change in Patient Reported Outcomes as a number score(Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months)
- Complications(Intra-operative, any time post-op upto 24 months)
- Clinical parameters in days(Immediate Post-operative)
- Peri operative clinical parameters(Intra-Operative)
- Intra-Operative clinical parameters in minutes(Intra-Operative)
- Changes in Radiographic Analysis in percentage(6weeks, 12 weeks, 6months, 12 months, 24 months)
- Peri operative clinical parameters in mgs(Immediate Post-operative)
研究者
研究点 (1)
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