NCT01495234已完成不适用
A Pilot Investigation of Recombinant Human Bone Morphogenetic Protein- 2/Biphasic Calcium Phosphate in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
Medtronic Spinal and Biologics0 个研究点目标入组 15 人开始时间: 1996年10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
- 15
- 主要终点
- Fusion Status
研究概览
简要总结
This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger clinical trial in a patient population requiring spinal fusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Subject has radiographically documented spinal degeneration with instability as documented by the presence of translation >= 4mm or angulation >= 5°.
- •Subject has intractable back pain which does not respond to conservative treatment and in the investigator's opinion, requires surgical spinal fusion.
- •Subject's pain is predominantly associated with the back.
- •Subject has only one level involvement at L3-L4, L4-L5, or L5-S
- •Subject is 18 years of age or greater at the time consent is given to participate in the study.
- •Subject is willing to comply with the study plan and sign the informed consent.
- •Subject is male or a non-pregnant, non-nursing female. All females of child-bearing age must agree to use adequate contraception for a period of no less than 16 weeks following surgery.
排除标准
- •Subject has primary spinal diagnosis of a disorder other than spinal degeneration with instability at the involved surgical level.
- •Subject has spinal stenosis or condition which requires a full laminectomy procedure.
- •Subject has had a previous fusion, discectomy or laminectomy procedure at L3-L4, L4-L5 or L5-S
- •Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids, methotrexate) or has a condition which requires postoperative medications that interfere with fusion (e.g., steroids, nonsteroidal antiinflammatory drugs, or methotrexate).
- •Subject has overt or active infection near the operative spinal region.
- •Subject has active systemic infection.
- •Subject has history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- •Subject's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
- •Subject has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/BCP implantation.
- •The subject requires electrical bone growth stimulation, allograft, or bone substitute as part of treatment.
- •Subject has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers Danlos syndrome, or osteogenesis imperfecta).
- •Subject has a known diagnosis of diabetes which requires treatment with medication.
- •Subject has received previous radiation therapy at the site to be fused.
- •Subject is unwilling to return for required follow-up visits.
- •Subject is a prisoner.
- •Subject has insufficient bone mass which precludes surgery (e.g., severe osteopenia or osteoporosis).
结局指标
主要结局
Fusion Status
时间窗: 12 month
Fusion will be met all of the following criteria: 1. Evidence of bridging trabecular bone; 2. Angular motion \< 5°; 3. Translational motion \<= 3mm; 4. No radiolucent lines spanning the entire fusion mass.
次要结局
- General Health Status (SF-36)(12 month)
- Oswestry Low Back Pain Disability Questionnaire Status(12 month)
- Neuro/Functional Status(12 month)
- Neurological Status(12 month)
研究者
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