The purpose of this trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal fusion in patients with cervical symptomatic degenerative disc disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Cornerstone-SR™ allograft bone containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) used in conjunction with ATLANTIS™ anterior cervical plate system.
Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system.
Overall Success
A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Neck Disability Index) Improvement; 3. maintenance or improvement in neurological status; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure".
Time frame: 12 month
Disc Height Measurement
Time frame: 12 month
General Health Status (SF-36)
Time frame: 12 month
Pain Status (neck pain, arm pain)
Time frame: 12 month
Patient Satisfaction
Time frame: 12 month
Patient Global Perceived Effect
Time frame: 12 month
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