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2009年7月2日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Degenerative disc disease that can be treated using Posterior Lumbar Interbody Fusion with Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods.
- 发起方
- ApaTech Ltd
- 入组人数
- 100
- 状态
- 招募中
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
相似试验
招募中
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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
进行中（未招募）
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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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