NCT01491373已完成不适用
A Feasibility Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Medtronic Spinal and Biologics0 个研究点目标入组 14 人开始时间: 1997年1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
- 14
- 主要终点
- Fusion
研究概览
简要总结
This study is designed to evaluate the feasibility of recombinant human bone morphogenetic protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® ) for anterior lumbar interbody fusion in patients with degenerative disc disease.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has degenerative disc disease as noted by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies.
- •Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.)
- •Has single level symptomatic degenerative involvement from L2 to S
- •Is between the ages of 18 and 65, inclusive, at the time of surgery.
- •Is willing to comply with the study plan and sign the Patient Informed Consent Form.
- •Has not responded to conservative treatment for a period of 5 months.
- •If of child-bearing potential, subject is non-pregnant (documented by a negative Pregnancy test within 72 hours of surgery), non-nursing female who agrees to use adequate contraception for 16 weeks following surgery
排除标准
- •Has spinal condition other than symptomatic degenerative disc disease at the involved surgical level.
- •Had previous anterior surgical procedures at the involved spinal level.
- •Has a condition which requires postoperative medications that interfere with fusion such as steroids or nonsteroidal anti-inflammatory drugs. (This does not include low dose aspirin for prophylactic anticoagulation.)
- •Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- •Has circulatory problems, such as thrombophlebitis, lymphedema, or vascular deficiency at the implant site.
- •Has symptomatic cardiac disease.
- •Has presence of active malignancy or history of cancer in the past 5 years.
- •Has overt or active infection.
- •Is obese, i.e., weight greater than 40% over ideal for their age and height.
- •Has fever (temperature > 101°F oral).
- •Has local inflammatory signs indicative of infection.
- •Has a documented metal allergy or intolerance.
- •Is involved in a worker's compensation or unresolved spinal litigation case.
- •Is mentally incompetent (either documented or in the opinion of the investigator).
- •Has psychogenic magnification of pain (in the opinion of the investigator).
- •Is a prisoner.
- •Is pregnant.
- •Is an alcohol and/or substance abuser.
- •Requires bone growth stimulation in the lumbar spine.
- •Is a tobacco user at the time of surgery.
- •Patient has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).
- •Patient has a history of autoimmune disease (systemic lupus erythematosus or dermatomyositis).
- •The subject has a history of exposure to injectable collagen implants.
- •Patient's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- •Patient 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/ACS implantation.
- •Patient has received any previous exposure to BMP.
- •The patient requires allograft or bone substitute as part of treatment.
- •Patient has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
- •Patient in the physician's opinion, would not be a good candidate for this surgical procedure.
结局指标
主要结局
Fusion
时间窗: 24 month
次要结局
- Pain Assessment (Oswestry Disability Index, ODI)(24 month)
- Neurological Status Assessment(24 month)
- Health status assessment (SF-36)(24 month)
研究者
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