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Interbody Device

DEXA-C Device for Degenerative Disc Disease (DEXA-C Trial)

N/A
Recruiting
Research Sponsored by Aurora Spine and Pain
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

DEXA-C Trial Summary

This trial tested a new medical device to help bones heal together faster in the neck.

Who is the study for?
This trial is for adults with degenerative disc disease who need cervical spine surgery (anterior cervical discectomy and fusion) at levels C3-7. They should have arm symptoms like pain or weakness due to nerve issues, confirmed by imaging tests, and must have tried non-surgical treatments for at least 6 weeks. People can't join if they've had recent neck surgery, severe spine joint wear-and-tear, need different types of neck surgeries, or belong to vulnerable groups unable to consent.Check my eligibility
What is being tested?
The DEXA-C Anterior Cervical Interbody System is being tested in this study. It's a device cleared by the FDA that's used during spinal fusion surgery in the neck area (cervical spine). The system is designed based on patients' bone density scans (DEXA) aiming to improve the rate at which bones grow together after surgery.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with anterior cervical discectomy and fusion may include infection, bleeding, pain at the graft site, nerve damage leading to weakness or numbness, problems with voice or swallowing due to laryngeal nerve irritation.

DEXA-C Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fusion Assesment
Secondary outcome measures
Subsidence

DEXA-C Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm ObservationalExperimental Treatment1 Intervention
Cervical Interbody Cage

Find a Location

Who is running the clinical trial?

Aurora Spine and PainLead Sponsor

Media Library

DEXA-C Cervical Interbody System (Interbody Device) Clinical Trial Eligibility Overview. Trial Name: NCT05883436 — N/A
DEXA-C Cervical Interbody System (Interbody Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05883436 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this experiment?

"Correct. Clinicaltrials.gov reports that the trial, which was first published on February 22nd 2023 is still actively recruiting participants with its most recent update dated May 30th 2023."

Answered by AI

How many participants are allowed to join this clinical trial?

"Affirmative. Information available on clinicaltrials.gov confirms that this medical trial has been actively recruiting since February 22nd of 2023 and is still searching for 80 participants at two different sites, the most recent update having occurred on May 30th 2023."

Answered by AI

Who else is applying?

What state do they live in?
California
Nevada
What site did they apply to?
UCI Center for Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Investigation of DEXA-C Anterior Cervical Interbody System
2023. "Investigation of DEXA-C Anterior Cervical Interbody System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05883436.
All > Degenerative Disc Disease
~30 spots leftby Feb 2025
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