NCT00758719已完成不适用
A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Radiographic Fusion
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.
详细描述
All subjects enrolled in this study will receive the The Biomet Osteobiologic Treatment System which is comprised of the SpF® Spine Fusion Stimulator and any or all of the following can be utilized in the study: any Pedicle Screw System, autograft and an Interbody Spacer
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must, in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
- •The subject must be diagnosed with degenerative disc disease at up to 2 levels from L2-S1 inclusive and undergoing up to 2 level posterior lumbar spinal fusion surgery with or without anterior column fusion.
- •Subjects must be between 18 and 75 years of age.
- •The patient must be skeletally mature (epiphyses closed).
排除标准
- •Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
- •Any active litigation.
- •Subject is currently involved in another investigational study.
- •Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
- •Subject is incarcerated.
- •More than 2 prior spine surgeries/revision surgeries or any previous spinal fusions at levels being currently treated.
- •Traumatic instability.
- •Any parathyroid or metabolic bone disease.
- •Any active malignancy.
- •Osteopenia/Osteoporosis - All subjects will be screened for osteoporosis using SCORE (Simple Calculated Osteoporosis Risk Estimation) with a threshold value of
- •All subjects with a SCORE value greater than 6 will be referred for Dual-energy X-ray absorptiometry (DEXA) Scan. Subjects with a T-Score of £-1-2.5 will be excluded.
结局指标
主要结局
Radiographic Fusion
时间窗: 12 Month
次要结局
- Neurologic Assessment, Maintenance or improvement from baseline(12 Month)
- Narcotic Use(24 month)
- Visual Analog Scale (VAS) change from baseline(24 Months)
- Oswestry Disability Index change from baseline(24 Month)
- Time to return to normal activity(24 month)
- Short Form Health Survey (SF-36) % change from baseline(24 Month)
- Time to return to work(24 month)
研究者
研究点 (4)
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