This is a prospective, multi-center controlled observational clinical study. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Each site will have a predetermined bonegraft extender to be used in all enrolled subjects at that site.
Study Type
OBSERVATIONAL
Enrollment
75
fusion surgery
Kenai Spine
Soldotna, Alaska, United States
Spine Care Institute
Daly City, California, United States
Spine Clinic of Monteray bay
Soquel, California, United States
Laser Spine Institute
Tampa, Florida, United States
Pain measured by VAS
1 to 10
Time frame: 2 years
Function measured by oswestry disability index
10 question score
Time frame: 2 years
Success of fusion
Fusion will be assessed by AP/Lat Flex/Ext radiographs
Time frame: 3 months, 6 months, 12 months, 24 months
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Polaris Spine
Atlanta, Georgia, United States
Chatham Orthopedic Associates
Savannah, Georgia, United States
Spine Institute of Idaho
Meridian, Idaho, United States
Southern Oregon Orthopedics
Medford, Oregon, United States