NCT01494493终止不适用
A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
Medtronic Spinal and Biologics0 个研究点目标入组 85 人开始时间: 2000年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 85
- 主要终点
- Overall success
研究概览
简要总结
The purpose of this clinical trial is to evaluate the implant (rhBMP-2/ACS/allograft bone dowel) as a method of facilitating spinal 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 —（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 or without leg pain, with degeneration of the disc confirmed by patient history ( e.g.,pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit and/or neurological deficit)and radiographic studies ( e.g., CT, MRl, X-Ray, etc.) to include one or more of the following:
- •instability( defined as angular motion > 5° and/or translation >= 2-4mm, based on Flex/Ext radiographs);
- •osteophyte formation;
- •decreased disc height;
- •thickening of ligamentous tissue;
- •disc degeneration or herniation; and/or
- •facet joint degeneration.
- •Has preoperative Oswestry score >
- •Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
- •Has single-level symptomatic degenerative involvement from L4 to S
- •Is at least 18 years of age, inclusive, at the time of surgery.
- •Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months.
- •If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
- •Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.
排除标准
- •Had previous anterior spinal fusion surgical procedure at the involved level.
- •Has posterior spinal instrumentation (which will not be removed) stabilizing the involved level or has had a previous posterior lumbar interbody fusion procedure at the involved level.
- •Has a condition which requires postoperative medications that interfere with fusion, such as steroids or nonsteroidal antiinflammatory drugs (this does not include low dose aspirin for prophylactic anticoagulation or perioperative steroids).
- •Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- •Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
- •Has overt or active bacterial infection, either local or systemic.
- •Is obese, i.e., weight greater than 40% over ideal for their age and height.
- •Has fever (temperature> 101°F oral) at the time of surgery.
- •Is mentally incompetent. If questionable, obtain psychiatric consult.
- •Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
- •Is a prisoner.
- •Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
- •Is a tobacco user at the time of surgery.
- •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).
- •Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- •Has a history of exposure to injectable collagen implants.
- •Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- •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.
- •Has received any previous exposure to any/all BMP's of either human or animal extraction.
- •Has a history of allergy to bovine products or a history of anaphylaxis.
- •Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
结局指标
主要结局
Overall success
时间窗: 24 month
A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Oswestry) improvement; 3. maintenance or improvement in neurological status; 4. no serious adverse event classified as implant associated or implant/surgical procedure associated; 5. no additional surgical procedure classified as a "failure."
次要结局
- Back and Leg Pain Status (Numerical Rating Scale)(24 month)
- General Health Status (SF-36)(24 month)
- Patient Global Perceived Effect(24 month)
- Disc Height Measurement(24 month)
- Patient Satisfaction(24 month)
研究者
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