Investigation of DEXA-C Anterior Cervical Interbody System

Degenerative Disc Disease Clinical Trial

— DEXA-C  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883436
• Other study ID #: 01-AUR-DEXA-23
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Aurora Spine and Pain
• Contact: Kristina R Ramey, M-PH
• Phone: 2703664534
• Email: kramey[@]auroraspine.us
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: February 22, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Must already be scheduled or planned for anterior cervical discectomy and fusion using the Dexa-C Anterior Interbody System C3-7 with supplemental fixation and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone meeting on-label criteria.

2. Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution).

3. Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy.

4. Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms.

5. At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication).

Exclusion Criteria:

1. History of cervical spine surgery less than 12 months prior to surgery.

2. Diagnosis of severe spondylosis.

3. Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery.

4. Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Orthopaedic Institute of Western KY	Metropolis	Illinois
United States	UCI Center for Clinical Research	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Spine and Pain

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion Assesment	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	12 months
Secondary	Subsidence	Secondary outcome measures will include subsidence. Patient reported outcomes (Neck Disability Index on a 0-50 scale (NDI) and Visual Analog Scale for Pain (VAS) on a 0-10 scale will be collected at follow up visits and assessed compared to baseline.	12 months