PMCF Neo Pedicle Screw and Cage Systems

Neo Medical

Status

Active, not recruiting

Conditions

Spinal Tumor

Degenerative Disc Disease

Trauma

Spondylolisthesis

Pseudoarthrosis of Spine

Spinal Stenosis

Treatments

Device: NEO Pedicle Screw System™

Device: Neo Cage System™

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT03956537

NeoPMCF01

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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