Investigation of DEXA-C Anterior Cervical Interbody System

Aurora Spine and Pain

Status: Enrolling

Conditions: Degenerative Disc Disease

Treatments: Device: DEXA-C Cervical Interbody System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05883436

01-AUR-DEXA-23

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

Single Arm Observational

Other group

Description:

Cervical Interbody Cage

Treatment:

Device: DEXA-C Cervical Interbody System