PMCF Neo Pedicle Screw and Cage Systems

Study Overview
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Brief Summary
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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.

Official Title
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Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study

Conditions
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Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Tumor, Trauma, Pseudoarthrosis of Spine

Intervention / Treatment
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* Device: NEO Pedicle Screw System™
* Device: Neo Cage System™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pedicle screw system alone<br> | Device: NEO Pedicle Screw System™<br>* The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.<br>|
| Pedicle screw system with cages<br> | Device: NEO Pedicle Screw System™<br>* The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.<br>Device: Neo Cage System™<br>* 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™<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient´s function from baseline to 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. | 12 months | 
| The rate of cage migration in cage-plus-screw systems. | Defined as posterior movement of the cage past the posterior wall of the vertebral body. | 12 months and 24 months post operatively | 
| The rate of pedicle screw loosening in screw only and cage-plus-screw systems. | A radiolucent zone, >1mm, surrounding the pedicle screw seen in radiograhs | 12 months and 24 months post operatively |