PMCF Neo Pedicle Screw and Cage Systems

Condition(s) studied

Investigational drug(s) / intervention(s)

NEO 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.

Neo 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™

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (2)

Other trials for the same condition