None listed
Conditions
Interventions
Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods and bone graft substitute (Actifuse ABX) with the bone graft laid on between the decorticated transverse processes of the spine.
Sponsors
ApaTech Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed