NCT01560273终止不适用
A Multi-Center Prospective Study Evaluation Aspen Spinous Process Fixation System for Use in Posterolateral Fusion (PLF) in Patients With Spondylolisthesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Absolute change in Oswestry Disability Index (ODI)
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
详细描述
Evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and older
- •Diagnosis of mild segmental instability on standing radiography lateral film defined as degenerative spondylolisthesis ≤ 4mm in dynamic imaging (i.e., flexion/extension)
- •Scheduled for an elective single-level posterior decompression and posterolateral fusion using AspenTM spinous process fixation system
- •Oswestry Disability Index (ODI) v 2.1 score >30%
- •Failed at least 3 months of conservative care (non-surgical) OR has clinical signs of neurological deterioration
- •Signed Informed Consent Form
排除标准
- •Pre-operative
- •Marked degenerative spondylolisthesis (>4mm)
- •Lesions requiring surgery involving two levels
- •Prior surgery at index level or adjacent level
- •Prior spinal fusion surgery
- •Isthmic or lytic spondylolisthesis
- •Incompetent or missing posterior arch at the affected level (e.g. complete laminectomy, pars defect)
- •Requires complete laminectomy at level of surgery
- •Facet joints at implant level are absent or fractured
- •Vertebral body compromise or acute fracture at implant level
- •Body mass Index (BMI) ≥ 35
- •Known allergy to titanium
- •Osteoporosis: SCORE (Simple Calculated Osteoporosis Risk Estimation) will be used to screen subjects requiring DEXA. Subjects with T-score < -2.5 will be excluded
- •Paget's disease, osteomalacia, or any other metabolic bone disease
- •Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids)
- •Planned use of additional segmental fixation (eg. facet screws, anterior/lateral plating, anchored cages)
- •Use of Bone Morphogenetic Protein (BMP)*
- •Unlikely to comply with the follow-up evaluation schedule
- •In the opinion of the Investigator, Subject has history of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation
- •Active participation in a clinical trial of another drug or device
- •Active systemic infection or any other health condition that would preclude surgery
- •History of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years
- •Pregnant or planning to become pregnant during study participation
- •Involvement in active litigation related to back problems at the time of screening
- •Direct involvement in the execution of this protocol
- •Pre-existing conditions that could interfere with the evaluation of outcome measures (e.g. musculoskeletal, neuromuscular, etc.)
- •Intra-operative Exclusion
- •Intra-operative visualization of a > 4mm spondylolisthesis not previously noted radiographically
- •Any change in the surgical procedure that violates the inclusion/exclusion criteria. (eg. switching to double level procedure; placing pedicle screws as posterior fixation).
结局指标
主要结局
Absolute change in Oswestry Disability Index (ODI)
时间窗: baseline to 12 months post-operative
次要结局
- Pain medication usage(Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months)
- Change in Zurich Claudication Questionnaire(Baseline, 12 months & 24 months)
- Operative parameters (estimate blood loss, surgery time, fluoroscopy time, and length of hospital stay)(Surgical Visit)
- Change in EQ-5D-3L(Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months)
- Title: Fusion success(12 Months post-operative)
- Neurological status(Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months)
- Change in Visual Analogue Scale (VAS) (pain)(Baseline, 6 weeks, 2 weeks, 3 months, 6 months, 12 months, & 24 months)
研究者
研究点 (5)
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