Phase
Condition
N/ATreatment
DEXA-C Cervical Interbody System
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must already be scheduled or planned for anterior cervical discectomy and fusionusing the Dexa-C Anterior Interbody System C3-7 with supplemental fixation and/orallogenic bone graft composed of cancellous, cortical, and/or cortico-cancellousbone meeting on-label criteria.
Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresisin a specific nerve root distribution).
Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7requiring open anterior cervical fusion and discectomy.
Diagnosis of degenerative disc disease by radiographic evidence of cervical discherniation and/or osteophytes accompanying clinical symptoms.
At least 6 weeks prior conservative treatment (i.e. physical therapy, painmedication).
Exclusion
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, orrevision surgery.
Any member of a vulnerable population (ie. minors, adults who lack the ability toconsent, pregnant women, etc.)
Study Design
Study Description
Connect with a study center
UCI Center for Clinical Research
Orange, California 92868
United StatesSite Not Available
UCI Center for Clinical Research
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Orthopaedic Institute of Western KY
Metropolis, Illinois 62960
United StatesSite Not Available
Orthopaedic Institute of Western KY
Paducah, Kentucky 42003
United StatesSite Not Available
Orthopaedic Institute of Western KY
Paducah 4048662, Kentucky 6254925 42003
United StatesActive - Recruiting
Koga Neurosurgery
Covington, Louisiana 70433
United StatesSite Not Available
Koga Neurosurgery
Covington 4321005, Louisiana 4331987 70433
United StatesActive - Recruiting
Optima Orthopedics
Oklahoma City, Oklahoma 73159
United StatesSite Not Available
Optima Orthopedics
Oklahoma City 4544349, Oklahoma 4544379 73159
United StatesActive - Recruiting
Center for Interventional Pain & Spine
Bryn Mawr, Pennsylvania 19010
United StatesSite Not Available

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