NCT01494454已完成不适用
A Clinical Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With Either the TSRH® Spinal System or the CD Horizon® Spinal System for Posterolateral Lumbar Fusion in Patients With DDD
Medtronic Spinal and Biologics0 个研究点目标入组 197 人开始时间: 1999年8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
- 197
- 主要终点
- Pain/Disability Status
研究概览
简要总结
This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal System in treatment of the 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° translation >= 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 one or two adjacent levels from L1 to S1 requiring fusion.
- •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, agrees to not become pregnant for 1 year following surgery.
- •Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.
排除标准
- •Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 spondylolisthesis at the involved levels.
- •Had previous spinal fusion surgical procedure at the involved levels.
- •Has a condition that requires postoperative medications that interfere with fusion, such as steroids.
- •Has been previously diagnosed with 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 grossly obese, i.e., weight > 40% over ideal for their age and height.
- •Has fever ( temperature > 101°F oral) at the time of surgery.
- •Has a documented titanium alloy allergy or intolerance.
- •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 usage.
- •Is a tobacco user at the time of surgery.
- •Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery ( e.g., NSAIDS, steroids or methotrexate).
- •Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- •Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
- •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.
- •Has received any previous exposure to any/all BMP's of either human or animal extraction.
- •Has a history of severe allergy ( 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
Pain/Disability Status
时间窗: 24 month
The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score \>= 15
Fusion
时间窗: 24 month
Fusion is defined as: 1. Evidence of bridging trabecular bone. 2. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs as determined by superimposing the two views, one upon the other; b. Less than 5° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs; 3. Absence of radiolucent lines completely through the fusion mass.
次要结局
- Patient global perceived effect(24 month)
- Neurological status(24 month)
- General health status (SF-36)(24 month)
- Patient satisfaction(24 month)
- Hip (Donor Site) pain(24 month)
- Pain status (back pain, leg pain)(24 month)
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