Degenerative Disc DiseaseDEXA-CNCT05883436
Investigation of DEXA-C Anterior Cervical Interbody System
A study testing DEXA-C Cervical Interbody System in people with Degenerative Disc Disease, run by Aurora Spine and Pain at 4 sites in United States.
Trial summary
FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- DEXA-C Cervical Interbody System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Feb 2023to 22 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution).
- Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy.
- Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms.
- At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication).
Who cannot join
- History of cervical spine surgery less than 12 months prior to surgery.
- Diagnosis of severe spondylosis.
- Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery.
- Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Koga Neurosurgery
Covington, Louisiana, 70433
Optima Orthopedics
Oklahoma City, Oklahoma, 73159
UCI Center for Clinical Research
Orange, California, 92868
Orthopaedic Institute of Western KY
Paducah, Kentucky, 42003
About this study
Official title: A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System
FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.
Read the 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.
- Conditions
- Degenerative Disc Disease
- Being tested
- DEXA-C Cervical Interbody System
- Keywords
- fusion, subsidence
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXA-C Cervical Interbody SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Observational | Other | Cervical Interbody Cage Receives: Device: DEXA-C Cervical Interbody System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start22 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion22 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurora Spine and Pain
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883436
- Sponsor's protocol ID
- 01-AUR-DEXA-23
- Acronym
- DEXA-C
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System
- ClinicalTrials.gov ID
- NCT05883436
- Acronym / sponsor ID
- DEXA-C / 01-AUR-DEXA-23
- Conditions
- Degenerative Disc Disease
- Keywords
- fusion, subsidence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Aurora Spine and PainIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 22 Feb 2027 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm Observational | Other | Device: DEXA-C Cervical Interbody SystemCervical Interbody Cage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution).
- Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy.
- Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms.
- At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication).
Key exclusion criteria (4 listed)
- History of cervical spine surgery less than 12 months prior to surgery.
- Diagnosis of severe spondylosis.
- Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery.
- Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXA-C Cervical Interbody SystemThe 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 | Device | Single Arm Observational |
Primary outcome
Fusion Assesment
Time frame: 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
1 secondary outcome
Subsidence
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEXA-C Cervical Interbody System in people with Degenerative Disc Disease, run by Aurora Spine and Pain at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion Assesment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.