EUCTR2009-012672-27-NL进行中（未招募）不适用
A prospective, randomised study comparing the use of Actifuse™ ABX synthetic bone substitute with INFUSE® in patients requiring posterolateral instrumented lumbar fusion with interbody fusion also referred to as: APPRAISE T1 (A Prospective PLF Randomised Actifuse InfuSe Evaluation Trial 1) - APPRAISE T1
ApaTech Limited0 个研究点开始时间: 2009年6月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each patient participating in the clinical trial must meet the following inclusion criteria:
- •1 Has 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).
- •2Has a preoperative Oswestry Back Disability Score of 30 or more.
- •3Aged 18 to 75 years and skeletally mature at time of surgery.
- •4Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications and/or spinal injections) for a period of six months.
- •5If of childbearing potential, patient is non-pregnant, non-nursing and agrees not to become pregnant for one year following surgery.
- •6Is willing to and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient meeting any of the following criteria is to be excluded from this trial:
- •1Has had previous failed attempts at fusion surgery at the involved level(s).
- •2Has a diagnosis of spinal infection tumour or trauma.
- •3Requires surgery at more than two (2) levels.
- •4Has osteoporosis (excluding osteopenia) as evidenced on plain X-rays, CT scans (or DEXA scan in cases of doubt).
- •5Is pregnant.
- •6Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
- •7Has 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.
- •8Has a history of autoimmune disease.
- •9Has a history of exposure to injectable collagen implants.
- •10Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- •11Has 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.
- •12Has received any previous exposure to any/all BMPs of either human or animal extraction.
- •13Has a history of allergy to bovine products or a history of general anaphylaxis.
- •14Has 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).
- •15Has any disease that would preclude accurate clinical evaluation (e.g., neuromuscular disease, etc.).
- •16Has 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).
- •17Has 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.
- •18Has overt or active bacterial infection, local or systemic, and/or a potential for bacteremia.
- •19Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
- •20Has a documented metal allergy or intolerance to titanium alloy or cobalt-chrome-molybdenum alloy.
- •21Is, in the opinion of the Principal Investigator or Co-Investigators, intellectually unable to co-operate with the study.
- •22Has chronic or acute renal and/or hepatic failure or prior history of renal or hepatic disease.
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