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FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Observational | Other | Cervical Interbody Cage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEXA-C Cervical Interbody System | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Martineck, PA | Contact | 716-870-7535 | smartineck@auroraspine.us | |
| Matthew Goldstone | Contact | 626-664-3364 | mgoldstone@auroraspine.us |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCI Center for Clinical Research | Recruiting | Orange | California | 92868 | United States |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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| Orthopaedic Institute of Western KY | Recruiting | Paducah | Kentucky | 42003 | United States |
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| Koga Neurosurgery | Recruiting | Covington | Louisiana | 70433 | United States |
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| Optima Orthopedics | Recruiting | Oklahoma City | Oklahoma | 73159 | United States |
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