Investigation of DEXA-C Anterior Cervical Interbody System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2027-02-22

Brief Summary

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

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Detailed Description

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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

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Degenerative Disc Disease

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm Observational

Cervical Interbody Cage

Group Type OTHER

DEXA-C Cervical Interbody System

Intervention Type DEVICE

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

Interventions

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DEXA-C Cervical Interbody System

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

Intervention Type DEVICE

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes