The purpose of this study is to show that the Kineflex\|C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 to C7.
The Kineflex\|C disc is a 3-piece modular design consisting of two cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in two foot print sizes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
343
Implant
Implant
Tower Orthopedics and Sports Medicine
Beverly Hills, California, United States
Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline
Time frame: 24 months
No major device related adverse events
Time frame: 24 months
Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline
Time frame: 24 months
Time to recovery
Time frame: 24 months
Disc height at 24 months compared to baseline
Time frame: 24 months
Adjacent level deterioration at 24 months compared to baseline
Time frame: 24 months
Progressive facet disease at 24 months compared to baseline
Time frame: 24months
Displacement or migration of the device
Time frame: 24 months
Odom's Criteria
Time frame: 24 months
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