We will investigate if the use of Inductos in a intervertebral cage will provide us with better and or faster fusion rates.
Conditions
Interventions
Trade Name: Inductos
Product Name: Inductos
Pharmaceutical Form: Impregnated pad
Sponsors
Sofamor - Danek
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Skeletally mature to 70 years of age. Subject is indicated for posterior fusion at one, two, or three levels from L1 to S1. Subject has a one or more of the following diagnoses supported by MRI, and/or CT Scan, and/or Plain X-rays, and/or Discography and physical examination performed by the Investigator : Degenerative Disc Disease Internal Disc Disruption Spinal Stenosis Herniated Nucleus Pulposus Spondylolisthesis (Isthmic-Lytic or Degenerative) Grade I or Grade II only Spondylolysis Failed Lumbar Laminectomy Syndrome Subject has no prior fusion attempts in the lumbar spine. Has experienced pain with or without functional deficit and/or neurologic deficit for a minimum three month period of time prior to surgery. Has failed to respond to non-operative treatment modalities for minimum three month period of time prior to surgery. Has normal bleeding parameters. Subject signs the approved Informed Consent Form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant at time of surgery or plans to become pregnant within 2 years following surgery. Number of levels to be fused are greater than 3. Subject has a lumbar spine deformity, i.e. scoliosis, kyphosis, flat back, ankylosing spondylitis Will not be available or will not make self available for follow-up visits in accordance with the protocol to at least 24 months. Currently implanted with a posterior instrumentation system. Mentally incompetent or prisoner. Subject is being treated with investigational devices for the same disorder. Active localized or systemic infection. Past spinal infection. Presence of disease entity or condition which precludes the possibility of bony fusion (i.e. metastatic cancer, long-term use of steroids, etc..). Is unable to undergo autologous grafting procedure (due to insufficient bone stock, osteopenia, or for other reasons). Has an immunosuppressive disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is there a faster and higher fusion ratio in a group of patients in which the intervetebral cage is filled with Inductos in comparison with patients where the cage is filled up with autologous bone graft.;Secondary Objective: ;Primary end point(s): Two years after surgery, through clinical, anamnestic and radiological investigation | — |
Countries
Belgium
Outcome results
None listed