A Prospective, Multi-Center Investigation of the DEXA-C Anterior Cervical Interbody System

UCI Specialty Area: Orthopaedics

Principal Investigator: Sohaib Zafar Hashmi

Official Title: A Prospective, Multi-Center Investigation of the DEXA-C Anterior Cervical Interbody System

A Study On:

Degenerative Disc Disease

Muscles and Bones - Musculoskeletal

Study 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.

Eligibility

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).

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.)

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

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