The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.
The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 foot print sizes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
514
Insertion of the Kineflex Lumbar ArtificialDisc
Insertion of the Charite
Tower Orthopedics and Sports Medicine
Beverly Hills, California, United States
Improvement in Oswestry Low Back Pain Disability Score at 24 months compared with baseline; no revision removal, supplemental fixation or device related reoperations and no major adverse event as defined by the study protocol
Time frame: 24 months
Maintenance or improvement in neurologic status
Time frame: 24 months
Pain improvement
Time frame: 24 months
Significant disc height increase
Time frame: 24 months
No displacement or migration of the device
Time frame: 24 months
Time to return to work
Time frame: 24 months
Time to recovery
Time frame: 24 months
Preservation of at least 4 degrees of motion in flexion/extension
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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...and 11 more locations