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 StatesActive - Recruiting
Orthopaedic Institute of Western KY
Metropolis, Illinois 62960
United StatesSite Not Available
Orthopaedic Institute of Western KY
Paducah, Kentucky 42003
United StatesActive - Recruiting
Koga Neurosurgery
Covington, Louisiana 70433
United StatesActive - Recruiting
Optima Orthopedics
Oklahoma City, Oklahoma 73159
United StatesActive - Recruiting
Center for Interventional Pain & Spine
Bryn Mawr, Pennsylvania 19010
United StatesSite Not Available
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