This study is being conducted to assess the radiographic (x-rays and CT scans) and clinical outcomes for the use of DTRAX Cervical Cage with DTRAX Bone Screw for the treatment of degenerative disc disease at one disc level with accompanying radicular symptoms in the cervical (neck) spine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
DTRAX Cervical Cage is an intervertebral fusion device that provides mechanical support to the spine. DTRAX Cervical Cage is intended to be used in cervical spine fusion surgery. DTRAX Bone Screw is indicated for use in arthrodesis and provides supplemental fixation. .
Neurospine Institute Medical Group
San Francisco, California, United States
Daytona Orthopaedic and Spinal Research Group
Daytona Beach, Florida, United States
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States
Louisiana State University Health Sciences Center - New Orleans (LSUHSC - NO)
Assess the radiographic outcome data on fusion status, device retention, and maintenance of segmental lordosis at the index level utilizing DTRAX Cervical Cage with DTRAX Bone Screw used in the treatment of cervical radiculopathy
Time frame: Baseline throughout 24 months post-operatively
Assess the clinical outcome data based Neck Disability Index (NDI)
Time frame: Baseline throughout 24 months post-operatively
Assess the clinical outcome data based SF-12 v2 Health Survey
Time frame: Baseline throughout 24 months post-operatively
Assess the clinical outcome data based the Visual Analogue Scale (Neck and Arm VAS)
Time frame: Baseline throughout 24 months post-operatively
Safety information will be evaluated by collecting the type, frequency, severity, and device and procedure-relatedness of adverse events
Time frame: Baseline throughout 24 months post-operatively
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New Orleans, Louisiana, United States
Upstate Orthopedics
East Syracuse, New York, United States
Southern New York NeuroSurgical Group, P.C.
Johnson City, New York, United States
Cary Orthopaedic Spine Specialists
Cary, North Carolina, United States