Clinical trial NCT05883436: Investigation of DEXA-C Anterior Cervical Interbody System
Official title: A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: fusion
subsidence
Lead sponsor: Aurora Spine and Pain
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The Dexa-C Study will be conducted at up to 10 investigative sites in the United States. It is anticipated that at least 40 single level subjects and at least 40 multiple level subjects will be enrolled into the Study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Fusion Assesment
timeFrame: 12 months
Secondary outcomes:
measure: Subsidence
timeFrame: 12 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCI Center for Clinical Research
state: California
city: Paducah
country: United States
facility: Orthopaedic Institute of Western KY
state: Kentucky
city: Covington
country: United States
facility: Koga Neurosurgery
state: Louisiana
city: Oklahoma City
country: United States
facility: Optima Orthopedics
state: Oklahoma
Study officials:
References: