Degenerative Disc Disease, Pseudoarthrosis of Spine, Spinal Stenosis, Spinal Tumor, Spondylolisthesis, Trauma
Conditions
Brief summary
The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.
Interventions
DEVICENEO Pedicle Screw System™
The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
DEVICENeo Cage System™
Neo Cage System™ is intended to be used with bone graft material to facilitate interbody fusion and to be used with the NEO Pedicle Screw System™
Sponsors
ConfinisCPM
Neo Medical SA
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has undergone or is intended to undergo surgery with the Neo Pedicle Screw System™, standalone or in combination with the Neo Cage System™, for any of the approved indications as defined in the respective labelling * Patient has participated in or is willing to participate in the routine postoperative follow-up program * Patient is willing to provide written informed consent
Exclusion criteria
* Patient is under the age of 18 or skeletally immature * Patient had or has a contraindication to surgery or to any of the implant systems used in the study, as defined in the respective labelling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient´s function from baseline to 12 months | 12 months | Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI). Zero is equated with no disability and 100 is the maximum disability possible. |
| The rate of cage migration in cage-plus-screw systems. | 12 months and 24 months post operatively | Defined as posterior movement of the cage past the posterior wall of the vertebral body. |
| The rate of pedicle screw loosening in screw only and cage-plus-screw systems. | 12 months and 24 months post operatively | A radiolucent zone, \>1mm, surrounding the pedicle screw seen in radiograhs |
Countries
Germany, Spain
Outcome results
None listed