NCT01018771已完成不适用
A Prospective, Randomised Study Comparing the Use of Actifuse (Trademark) Advanced Bone Matrix (ABX) Synthetic Bone Substitute With INFUSE (Trademark) on Fusion in Patients Requiring Posterolateral Instrumented Lumbar Fusion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Fusion, defined as evidence of bridging trabecular bone present at 1 year
研究概览
简要总结
This is a prospective randomised study.
Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion.
Secondary objectives: Assess clinical outcome measurements.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have degenerative disc disease of the lumbar spine as indicated by back pain of discogenic/degenerative origin with or without leg pain and has one or more of the following conditions as documented by Plain X-Rays, CT Scan or MRI Scan:
- •Modic changes.
- •High intensity changes in the annulus.
- •Loss of disc height.
- •Decreased hydration of the disc.
- •Canal stenosis with or without Spondylotic slip.
- •Gross facet joint changes requiring fusion for treatment.
- •Have documented annular pathology by other means. (e.g. with discography).
- •Have a preoperative Oswestry Back Disability Score of 30 or more.
- •Aged 18 to 75 years and skeletally mature at time of surgery.
- •Have not responded to non-operative treatment (e.g. bed rest, physical therapy, medications and/or spinal injections) for a period of six months.
- •If of childbearing potential, patient is non-pregnant, non-nursing and agrees not to become pregnant for one year following surgery.
- •Is will to and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
排除标准
- •Has had previous failed attempts at fusion surgery at the involved level(s).
- •Has a diagnosis of spinal infection tumour or trauma.
- •Requires surgery at more than two (2) levels.
- •Has osteoporosis (excluding osteopenia) as evidenced on plain X-rays, CT Scans (or DEXA scan in cases of doubt).
- •Is pregnant.
- •Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
- •Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g. steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs.
- •Has a history of autoimmune disease.
- •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 (device and/or pharmaceutical) within 30 days prior to surgery or such treatment is planned during the 24 months following surgery.
- •Has received any previous exposure to any/all BMPs of either human or animal extraction.
- •Has a history of allergy to bovine products or a history of anaphylaxis.
- •Has a history of any endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal oseodystrophy, Ehlos-Danlos syndrome or Osteogenesis Imperfecta).
- •Has any disease that would preclude accurate clinical evaluation (e.g. neuromuscular disease etc).
- •Has a primary diagnosis of a spinal disorder other than degenerative disc disease or other conditions as set out in "Inclusions" above at the involved level(s).
- •Has a condition that requires postoperative medications that interfere with fusion, such as steroids or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative, non-steroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
- •Has overt or active bacterial infection, local or systemic and/or a potential for bacteremia.
- •Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
- •Has a documented metal allergy or intolerance to titanium alloy or cobalt-chrome-molybdenum alloy.
- •Who, in the opinion of the Principal Investigator or Co-Investigators, is intellectually unable to co-operate with the study.
- •Has chronic or acute renal and/or hepatic failure or prior history of renal or hepatic disease.
结局指标
主要结局
Fusion, defined as evidence of bridging trabecular bone present at 1 year
时间窗: 1 year
次要结局
- Improvement in the following clinical outcomes measurements: Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire; Quality of Life as measured by Short Form Health Survey (SF36)and Neurological Status(1 year)
研究者
研究点 (2)
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