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RecruitingACTRN12609000527268

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 with interbody fusion

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.

Sponsor

ApaTech Ltd

Enrollment

100 participants

Start Date

Jun 27, 2007

Study Type

Interventional

Conditions

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Inclusion Criteria9

  • 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.

Exclusion Criteria5

  • 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.

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Interventions

Posterior Lumbar Interbody Fusion with Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods and bone graft substitute (Actifuse ABX), with the bone g

Posterior Lumbar Interbody Fusion with Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods and bone graft substitute (Actifuse ABX), with the bone graft substitute laid on between the decorticated transverse processes of the spine.

Locations(1)

Netherlands

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ACTRN12609000527268