NCT03828136

Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion

Safety and Effectiveness of Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion. A Randomized, Controlled, Non-inferiority, Pivotal Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Bio2 Technologies · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Accepted

Summary

A prospective, multicenter, randomized, concurrently controlled, noninferiority clinical trial to compare the safety and effectiveness of instrumented Bio2 Vitrium Cervical Interbody Device in anterior cervical discectomy and fusion (ACDF) with structural allograft bone and local autologous bone graft in treating patients with a symptomatic degenerative cervical disc disease at one level from C3/C4 to C7/T1.

Detailed description

The study will evaluate if Bio2 Vitrium® Cervical Interbody Device (VCIBD) is non-inferior to allograft cage in single-level ACDF with the use of local autologous bone. VCIBD is a restorable cervical interbody cage for the treatment of fusion, following discectomy, of the cervical spine from C3/C4 disc space to the C7/T1 disc space. The material used to manufacture the implant is 13-93 bioactive glass, which is a silicate-based material as described in ASTM F1538-03(R2017). The implant has high porosity and strength and does not contain any biological material or constitute a combination product. The device has a central lumen for packing with autograft. VCIBD is intended to be used with a supplemental fixation system. The device, when placed between the vertebrae, provides mechanical stability and prevents subsidence prior to bone ingrowth. It restores and maintains the intervertebral space during the fusion process. The porosity and material characteristics provide an osteoconductive matrix that supports bone ingrowth. Additional stabilization is provided by supplemental fixation using anterior cervical plate. The implant incorporates a central lumen, which allows for the cage to be packed with autogenous bone graft.

Conditions

• Symptomatic Cervical Disc Disease

Interventions

Type	Name	Description
DEVICE	Novum Vitrium® Cervical Interbody Device	For spinal fusion procedure at one level (C3 to T1) of the cervical spine.
DEVICE	Allograft Ring or Block	Standard of Care

Timeline

• Start date: 2019-04-24
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2019-02-04
• Last updated: 2022-04-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study