Investigation of DEXA-C Anterior Cervical Interbody System

Not Applicable

Recruiting

• Conditions: Degenerative Disc Disease
• Interventions: Device: DEXA-C Cervical Interbody System

• Registration Number: NCT05883436
• Lead Sponsor: Aurora Spine and Pain

Brief 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.

Study Timeline

• Study Start: 2023-02-22
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-02-22
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single Arm Observational	DEXA-C Cervical Interbody System	Cervical Interbody Cage

Primary Outcome Measures

Name	Time	Method
Fusion Assesment	12 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

Secondary Outcome Measures

Name	Time	Method
Subsidence	12 months	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.

Trial Locations

Locations (4)

Optima Orthopedics; 🇺🇸 Oklahoma City, Oklahoma, United States

UCI Center for Clinical Research; 🇺🇸 Orange, California, United States

Orthopaedic Institute of Western KY; 🇺🇸 Paducah, Kentucky, United States

Koga Neurosurgery; 🇺🇸 Covington, Louisiana, United States