ACTRN12609000548235
Recruiting
Not Applicable
A prospective, randomised study comparing the use of Actifuse (trademark) Advanced Bone MatriX (ABX) synthetic bone substitute with INFUSE (registered trademark) on fusion in patients requiring posterolateral instrumented lumbar fusion.
ApaTech Ltd0 sites100 target enrollmentJuly 7, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative disc disease that can be treated using Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods.
- Sponsor
- ApaTech Ltd
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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