NCT05883436

Investigation of DEXA-C Anterior Cervical Interbody System

A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Aurora Spine and Pain · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.

Detailed description

The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. Device system is designed for use with supplemental fixation and autograft and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach. The Dexa-C clinical study will collect data on those patients who have been treated with Dexa-C Anterior Cervical Interbody System to allow for a better understanding of outcomes associated with it.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	DEXA-C Cervical Interbody System	The Dexa-C Cervical Interbody System is intended for use on patients who require anterior cervical discectomy and fusion surgery. The system implants an interbody spacer(s) into the cervical intervertebral body space(s) to stabilize and fuse the level(s). Allograft will be used in the spacer and the spinal segment(s) are fixed with an anterior cervical plate

Timeline

• Start date: 2023-02-22
• Primary completion: 2026-12-31
• Completion: 2027-02-22
• First posted: 2023-06-01
• Last updated: 2025-10-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study