NCT00437190已完成不适用
Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease
Medtronic Spinal and Biologics75 个研究点 分布在 1 个国家目标入组 494 人开始时间: 2003年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 494
- 试验地点
- 75
- 主要终点
- Improvement in patient pain and ability to function
研究概览
简要总结
The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.
详细描述
Bryan(R) Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single level discectomy for intractable radiculopathy and/or myelopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The indication studied was degenerative disc disease (DDD) at a single level between C3 and C7 for any combination of disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.
- •The following additional inclusion criteria had to be present:
- •At least 6 weeks unsuccessful conservative treatment, except in cases of myelopathy requiring immediate treatment (e.g., acute onset of clinically significant signs);
- •Requirement for surgical treatment demonstrated by CT, myelography and CT, and/or MRI;
- •Skeletally mature (≥ 21 years of age);
- •Preoperative Neck Disability Index score of ≥ 30 and at least one clinical sign associated with level to be treated;
- •Willing to sign informed consent and comply with protocol.
排除标准
- •Subjects were excluded if they had any of the following:
- •Any of the following at the treated level:
- •Significant cervical anatomical deformity; e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
- •Moderate to advanced spondylosis. Patients who demonstrate advanced degenerative changes. Such advanced changes are characterized by any one or combination of the following: bridging osteophytes, marked reduction or absence of motion, collapse of the intervertebral disc space of greater than 50% of its normal height;
- •Radiographic signs of subluxation greater than 3.5 mm;
- •Angulation of the disc space more than 11 degrees greater than adjacent segments;
- •Significant kyphotic deformity or significant reversal of lordosis;
- •Axial neck pain as the solitary symptom;
- •Previous cervical spine surgery;
- •Metabolic bone disease, such as osteoporosis, defined as a BMD T-score equal to or worse than 2.
- •If significant radiolucence is detected, a BMD scan in the spine, wrist, and femoral neck must be obtained.
- •Active systemic infection or infection at the operative site;
- •Known allergy or to titanium, polyurethane, or ethylene oxide residuals;
- •Concomitant conditions requiring steroid treatment;
- •Diabetes mellitus requiring daily insulin management;
- •Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index;
- •A medical condition that may interfere with the postoperative management program, such as advanced emphysema or Alzheimer's disease;
- •A medical condition that may result in patient death prior to study completion: unstable cardiac disease, active malignancy;
- •Pregnant;
- •Current or recent alcohol and/or drug abuser requiring intervention;
- •Signs of being geographically unstable, such as recent or pending divorce, or high level of job dissatisfaction.
结局指标
主要结局
Improvement in patient pain and ability to function
时间窗: 24 months
The self-administered Neck Disability Index patient questionnaire is used to assess patient pain and ability to function. A successful outcome will be declared if: Postoperative Score - Postoperative Score is ≥ 15.
次要结局
未报告次要终点
研究者
研究点 (75)
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