A retrospective parallel group comparison study to support expansion of the indication of the company's FDA approved Spinalogic™ device to include the cervical spine. The SpinalogicTM device was initially approved by FDA as an adjunct to one- or two-level lumbar fusion (P910066/S011). It is a non-invasive bone growth stimulator (BGS) that generates a combined magnetic field (CMF) that has been proven to accelerate bone healing and fusion in the lumbar spine.
Study Type
OBSERVATIONAL
Enrollment
400
The SpinalogicTM is a portable, battery-powered, microprocessor-controlled, non-invasive bone growth stimulator. The device is currently approved and commercially indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
SIOSD
San Diego, California, United States
RECRUITINGBSSNY
White Plains, New York, United States
RECRUITINGTime to fusion
Comparison of the cervical fusion rate between treated and control group patients
Time frame: 12 months
Patient Reported Outcome Measures VAS
VAS Pain Score
Time frame: 12 months
Patient Reported Outcome Measures NDI
Neck Disability Index
Time frame: 12 months
Patient Reported Outcome Measures OC
Odum's Criteria
Time frame: 12 months
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