A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To evaluate bone fusion;
研究概览
简要总结
The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable spine joints. A patient may or may not receive rods and screws with the use of bone graft materials to facilitate bone growth and a fusion thus preventing movement of the bones of the spine.
In this research study, bone graft substitute material called Bone Morphogenetic Protein-2 known as BMP-2 Infuse will be used. No hip bone will be used. The surgical procedure will consist of BMP-2 Infuse with or without the use of rods and screws.
详细描述
In this study we will be using BMP-2 Infuse instead of the iliac crest bone graft for the spinal fusion. The BMP-2 Infuse has been researched in the only completed clinical trial for spinal fusions. It has demonstrated equivalence to the iliac crest bone graft with regard to both fusion rate and clinical outcome.
Currently, the acceptable standard of care for spinal fusion surgery requires instrumented or non-instrumented procedure with the use of bone graft materials, to facilitate bone growth, and a fusion, thus eliminating movement between the inciting vertebrae.
In this study, the surgical procedure will be BMP-2 Infuse with instrumentation or BMP-2 Infuse alone.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patient has a systemic infection.
- •Patient has had more than one previous non-fusion spinal surgery at the involved level.
- •Patient requires fusion at more than 2 levels.
- •Patient has pseudoarthroses from a previous fusion attempt.
- •Patient has highly communicable diseases, inflammatory or autoimmune disease (e.g.osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis). A note to file written by the investigator will permit a patient into the study who experiences a mild case which will not affect the outcome of the study.
- •Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
- •Patient has a significant medical history that, in the Investigator's opinion would not make them a good study candidate.
- •Patient requires interbody cage fusion or non-pedicle screw instrumentation.
- •Pregnancy.
- •Has presence of active malignancy (except basal cell carcinoma of the skin)
- •Has a history of severe allergy (anaphylaxis)
- •Is grossly obese, i.e. weight over 40% over ideal for their height and age.
- •Has a fever (temperature over 101 F oral)
- •Has an allergy to the BMP-2
- •Has allergy to bovine products
- •Has an allergy to collagen implants
- •Is mentally incompetent(if questionable, obtain psychiatric consult)
- •Is a prisoner, a transient or have been treated in an inpatient substance abuse program for alcohol and/or drug abuse within six months prior to proposed study enrollment.
- •Has received drugs which may interfere with bone metabolism within two weeks prior to the planned surgery
- •Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
- •Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)
结局指标
主要结局
To evaluate bone fusion;
时间窗: 3mon., 6mon., 12mon., 24mon
Radiology tests; CT spine 24mon.
时间窗: 3mon., 6mon., 12mon., 24mon
Clinical neurological evaluations; patient questionnaires
时间窗: 3mon., 6mon., 12mon., 24mon
次要结局
- Hospital and surgical data(hospitalization;)
- Adverse events(hospitalization, clinic visits, unscheduled visits)
研究者
David Alexander
Principal Investigator
Nova Scotia Health Authority