ACTRN12609000527268招募中不适用
A prospective, randomised study comparing the use of Actifus (trademark) Advanced Bone MatriX (ABX) synthetic bone substitute with INFUSE (registered trademark) on fusion in patients requiring posterolateral instrumented lumbar fusion with interbody fusion.
ApaTech Ltd0 个研究点目标入组 100 人开始时间: 2009年7月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •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 Magnetic Resonance Imaging (MRI) scan:
- •a)Modic changes.
- •b)High intensity changes in the annulus.
- •c)Loss of disc height.
- •d)Decreased hydration of the disc.
- •e)Canal stenosis with or without spondylotic slip.
- •f)Gross facet joint changes requiring fusion for treatment.
- •g)Have documented annular pathology by other means. (e.g., with discography).
- •Has a preoperative Oswestry Back Disability Score of 30 or more.
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 Dual X-ray Absorptometry (DEXA) scan in cases of doubt).
- •Is pregnant.
研究者
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A prospective, randomised study comparing the use of Actifuse (trademark) Advanced Bone MatriX (ABX) synthetic bone substitute with INFUSE (registered trademark) in patients requiring posterolateral instrumented lumbar fusion.Degenerative disc disease that can be treated using Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods.Musculoskeletal - Other muscular and skeletal disordersSurgery - Surgical techniquesACTRN12609000548235ApaTech Ltd100
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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 T1Prospective trial participants will have been diagnosed with degenerative disc disease with a treatment option of decompression and Interbody Fusion with Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods.MedDRA version: 9.1Level: LLTClassification code 10024992Term: Lumbar disc diseaseEUCTR2009-012672-27-NLApaTech Limited
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