Back to resultsInvestigation of DEXA-C Anterior Cervical Interbody System (DEXA-C)
Primary Purpose
Degenerative Disc Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DEXA-C Cervical Interbody System
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring fusion, subsidence
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.)
Sites / Locations
- UCI Center for Clinical Research
- Orthopaedic Institute of Western KYRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm Observational
Arm Description
Cervical Interbody Cage
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05883436
Brief Title
Investigation of DEXA-C Anterior Cervical Interbody System
Acronym
DEXA-C
Official Title
A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
February 22, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurora Spine and Pain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
fusion, subsidence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm Observational
Arm Type
Other
Arm Description
Cervical Interbody Cage
Intervention Type
Device
Intervention Name(s)
DEXA-C Cervical Interbody System
Intervention Description
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
Primary Outcome Measure Information:
Title
Fusion Assesment
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Subsidence
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina R Ramey, M-PH
Phone
2703664534
Email
kramey@auroraspine.us
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Martineck, PA
Phone
7168707535
Email
martineck@verizon.net
Facility Information:
Facility Name
UCI Center for Clinical Research
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryder Maruska
Email
rmaruska@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Nitin Bhatia, MD
Facility Name
Orthopaedic Institute of Western KY
City
Metropolis
State/Province
Illinois
ZIP/Postal Code
62960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Vinson
Phone
270-442-9461
Ext
2142
Email
rvinson@oiwky.com
First Name & Middle Initial & Last Name & Degree
Kenneth B Strenge, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of DEXA-C Anterior Cervical Interbody System
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