The purpose of this clinical trial is to assess the safety and effectiveness of the Investigational implant as compared to the Control implant in the treatment of patients with one level or two adjacent levels of cervical symptomatic degenerative disc disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
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.
Fusion
Fusion is defined as: * No evidence of motion as defined by: less than 4° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs. * No radiolucency greater than 2mm of thickness covering more than 50% of superior or inferior graft surface. * Evidence of bridging trabecular bone.
Time frame: 24 month
Pain/Disability Status
The self-administered Neck Disability Index will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score \>= 15
Time frame: 24 month
Neurological Status
Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.
Time frame: 24 month
Time to fusion
Time frame: 24 month
Hip (Donor Site) Pain
Time frame: 24 month
General Health Status (SF-36)
Time frame: 24 month
Pain Status (neck pain, arm pain)
Time frame: 24 month
Patient Satisfaction
Time frame: 24 month
Patient Global Perceived Effect
Time frame: 24 month
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