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

  • End date
    Sep 13, 2024
  • participants needed
  • sponsor
    Neo Medical SA
Updated on 13 October 2022


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.

Condition Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Tumor, Trauma, Pseudoarthrosis of Spine
Treatment NEO Pedicle Screw System™, Neo Cage System™
Clinical Study IdentifierNCT03956537
SponsorNeo Medical SA
Last Modified on13 October 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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