Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- Neo Medical SA
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Change in patient´s function from baseline to 12 months
- Status
- Active, Not Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in patient´s function from baseline to 12 months
Time Frame: 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 pedicle screw loosening in screw only and cage-plus-screw systems.
Time Frame: 12 months and 24 months post operatively
A radiolucent zone, \>1mm, surrounding the pedicle screw seen in radiograhs
The rate of cage migration in cage-plus-screw systems.
Time Frame: 12 months and 24 months post operatively
Defined as posterior movement of the cage past the posterior wall of the vertebral body.