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Bone-Matched implant aims to boost neck surgery success

NCT ID NCT05883436

Disease control Sponsor: Aurora Spine and Pain Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This study is testing a new spinal implant called the DEXA-C, which is designed to match a patient's bone density scan to improve fusion after cervical disc surgery. About 80 adults with degenerative disc disease and arm symptoms will receive the implant and be followed for 12 months. The main goal is to see if the bone fuses properly, with secondary measures of pain and disability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DEXA-C Cervical Interbody System (a spinal implant device)
What this could lead to
If successful, this could lead to a more personalized spinal fusion device that improves bone healing and reduces complications after neck surgery.
What could go wrong
This is a small, early-stage study with no control group, so results may not prove the device is better than existing options. Risks include typical surgery complications like infection, implant failure, or non-union.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

71 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.)

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Conditions

The condition(s) this trial relates to.

cervical disk degenerative disorder intervertebral disk degenerative disorder lumbar disk degenerative disorder radiculopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative disc disease

Contacts and locations

Locations

  • Koga Neurosurgery

    Covington, Louisiana, 70433, United States

  • Optima Orthopedics

    Oklahoma City, Oklahoma, 73159, United States

  • Orthopaedic Institute of Western KY

    Paducah, Kentucky, 42003, United States

  • UCI Center for Clinical Research

    Orange, California, 92868, United States

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