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Anterior Cervical Interbody Device FDA Clinical Trial

Vitrium is currently in an active FDA IDE clinical trial for cervical interbody spinal fusion.

Novum Medical is enrolling up to 168 patients in a prospective, randomized, controlled, multi-center clinical trial assessing its safety and efficacy compared to allograft (human cadaver bone). Patients will undergo a Anterior Cervical Discectomy and Fusion (ACDF) and receive either a Vitrium Interbody Device (IBD) or allograft bone (which is the standard of care) implanted into the diseased disc space prior to placement of the screw/plate fixation construct.

Details of the study can be found at under the Identifier: NCT03828136

Caution: Investigational Device. Limited by Federal (or United States) Law to investigational use.

Upon implantation
Gradual Replacement
Patient’s bone replaces implant and covers fusion area
Disc area completely replaced with patient’s bone*

Representation of Vitrium Cervical lnterbody Device transitioning into bone showing potential full endplate fusion coverage

*The clinical trial requires implantation with an anterior cervical metal plate, not illustrated in all graphics above in order to show bone fusion procession.

The clinical study offers a unique material that encourages bone growth, allowing your body to heal on its own. After the fusion process is complete with traditional fusion implant devices, the metal or plastic left behind is, in most cases, no longer needed or necessary to be in the body. The goal of the study is to show Vitrium is replaced as new bone takes over, providing a stable, natural fusion with no metal or plastic remaining in
the fusion site.

The Vitrium IBD is temporary as it transitions to natural bone leaving no foreign material in the disc space.

Vitrium’s Transition into bone

Caution: Investigational Device. Limited by Federal (or United States) Law to investigational use.

Educational Video for Prospective Patients

Access Code Provided by an Approved Clinical Trial Location