NCT01323387已完成不适用
Lumbar Degenerative Disc Disease Treated With
Synthes USA HQ, Inc.0 个研究点目标入组 178 人开始时间: 2004年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 主要终点
- Number of Subjects With Successful Radiographic Fusion
研究概览
简要总结
Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.
The primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is evaluation of the patient's quality of life, pain and function.
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
- 是
入选标准
- •One or Two level (consecutive) degenerative disc disease between L2 and S
- •Degenerative disc disease is defined as follows:
- •Chronic pain (confirmed by patient exams and history) of discogenic origin, confirmed by radiographic evidence (e.g. MRI, discogram) two or more of the following:
- •Modic type 2 endplate changes on T2 weighted MRI
- •high intensity zone signal on T2 weighted MRI
- •positive discogram with negative controls
- •dark disc (diminished T2 weighted signal)
- •decreased disc height
- •Has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment
- •Has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment
- •Skeletally mature and at least 18 years of age
- •Signs the approved Informed Consent Document
- •Is available for long term follow-up and interval visits
排除标准
- •Has more than 2 levels to be instrumented
- •Has had a previous fusion attempt at the involved level(s)
- •Has had more than two previous open, lumbar spine surgical procedures at the involved level(s)
- •Currently implanted with anterior instrumentation at the involved level(s)
- •Patient would be classified as morbidly obese BMI > 35
- •Active localized or systemic infection
- •Presence of a disease entity or condition which significantly affects the possibility of bony fusion (e.g., osteoporosis, metastatic cancer, long-term use of steroids, etc.)
- •Has an immunosuppressive disorder
- •Pregnant or interested in becoming pregnant during the study.
- •Has a known sensitivity to device materials
- •Mentally incompetent or prisoner
- •Currently a participant in another study for the same indications.
研究组 & 干预措施
Treatment
Other
Interbody fusions with Anterior Plating
干预措施: Interbody Fusion (Device)
结局指标
主要结局
Number of Subjects With Successful Radiographic Fusion
时间窗: 24 Months
CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.
次要结局
- Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline.(24 Months)
- Pain Scores on the Numeric Rating Scale (NRS)(Baseline and 24 Months)
- Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline(24 Months)
- Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline(Baseline and 24 Months)
- SF-12 Physical Composite Score (PCS) Summary(Baseline and 24 Months)
- SF-12 Mental Composite Score (MCS) Summary(Baseline and 24 Months)
- Oswestry Disability Index (ODI) Summary(Baseline and 24 Months)
研究者
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