NCT01491477终止不适用
Study of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the Cornerstone-SR™ Allograft Ring and the ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease
Medtronic Spinal and Biologics0 个研究点目标入组 3 人开始时间: 2002年4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
- 3
- 主要终点
- Overall Success
研究概览
简要总结
The purpose of this trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal fusion in patients with cervical symptomatic 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cervical disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by diagnostic imaging procedures:
- •herniated disc;
- •osteophyte formation;
- •decreased disc height;
- •thickening of ligamentous tissue;
- •disc degeneration; and/or
- •facet joint degeneration.
- •Has preoperative Neck Disability Index score > 30;
- •Has single cervical disc disease level requiring fusion from C2 to C7;
- •No previous surgical intervention at the involved fusion level;
- •Unresponsive to nonoperative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root or spinal cord compression in face of continued nonoperative management;
- •Is at least 18 years of age, inclusive at time of surgery;
- •If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery;
- •Is willing and able to comply with study plan and sign the consent form.
排除标准
- •Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level.
- •Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged non-steroidal anti-inflammatory drugs excluding routine perioperative anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
- •Has been previously diagnosed with osteopenia, or osteomalacia.
- •Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility).
- •Postmenopausal Non-Black female over 60 years of age and weighs less than 140 pounds.
- •Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
- •Male over the age of
- •Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.
- •If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture, the patient is excluded from the study.
- •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.
- •Has a documented titanium alloy allergy or intolerance.
- •Is mentally incompetent. If questionable, obtain psychiatric consult.
- •Is a prisoner.
- •Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
- •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), excluding routine perioperative anti-inflammatory drugs.
- •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.
结局指标
主要结局
Overall Success
时间窗: 12 month
A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Neck Disability Index) 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
- Disc Height Measurement(12 month)
- General Health Status (SF-36)(12 month)
- Pain Status (neck pain, arm pain)(12 month)
- Patient Satisfaction(12 month)
- Patient Global Perceived Effect(12 month)
研究者
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