The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.
Study Type
OBSERVATIONAL
Enrollment
325
Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI). It will be assessed if the improvement in ODI since the pre-surgery status is at least 15 points
Time frame: 5 years
Patient has not undergone any reoperations, removals, revisions, or supplemental fixations;
Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device.
Time frame: 5 years
Patient has not had any major device related complications
Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 2 years and 5 years.
Time frame: 5 years
Patient has not undergone any Epidural injections
Assessment of lumbar epidural injections
Time frame: 5 years
Zurich Claudication Questionnaire (ZCQ)
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Time frame: 5 years
Quality of Life
Assessment of the patient's Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L
Time frame: 5 years
VAS Leg Pain
Change in the assessment of leg pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).
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Center for Neurology and Spine
Phoenix, Arizona, United States
Arizona Brain and Spine
Scottsdale, Arizona, United States
Northwest NeuroSpecialists
Tucson, Arizona, United States
The Spine Institute, Center for Spine Restoration
Santa Monica, California, United States
Cantor Spine institute
Fort Lauderdale, Florida, United States
Southeastern Integrated Medical
Gainesville, Florida, United States
The Orthopaedic Institute
Gainesville, Florida, United States
The BACK Center
Melbourne, Florida, United States
All Florida Orthopaedics
St. Petersburg, Florida, United States
Laser Spine Institute
Tampa, Florida, United States
...and 18 more locations
Time frame: 5 years
VAS Back Pain
Change in the assessment of back pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).
Time frame: 5 years