Investigation of DEXA-C Anterior Cervical Interbody System for Degenerative Disc Disease
This study is looking at the DEXA-C Cervical Interbody System, a device already approved by the FDA, for people with degenerative disc disease (DDD) in their neck. This device is used during a surgery called anterior cervical discectomy and fusion (ACDF) to help stabilize and fuse bones in the neck. The study aims to understand how well patients do after receiving this system. Success in this study will be measured by how well the bones fuse together, which will be checked 12 months after surgery. You might be able to join if you are an adult already scheduled for ACDF surgery using the Dexa-C system and have nerve pain (radicular signs and symptoms) in your arms. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 80 participants. It is designed to collect data on patients treated with the Dexa-C system.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for fusion assessment at 12 months after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Investigation of DEXA-C Anterior Cervical Interbody System
At a glance
Conditions
Where it's being run
4 sites across 4 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Fusion Assesment12 months
The primary outcomes of interest for this study will be fusion assessment at 3 months, 6 months and 12 months post-surgery. Fusion assessment from Static and Dynamic X-Ray (AP/LAT/Flex/Ex) using the following criteria: Bridging bone inside or outside of graft No lucencies at the graft-vertebral body junction Motion \< 1mm