A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients

A Retrospective Study to Examine the Effect of Adjuvant Combined Magnetic Field Stimulation on Primary Anterior Cervical Discectomy and Fusion (ACDF) Patients

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.

Inclusion Criteria

• Male or Female aged 18-75 years.
• Primary anterior cervical discectomy fusion (ACDF) and required two level spinal fusion or were active smokers and required either single or two level spinal fusion.
• Pain VAS score >5 and/or extreme weakness at target operative level(s).
• At least one post operative clinical outcome assessment (VAS pain/ NDI/OC score) at each follow up interval.
• Completed 6 month follow up visit or time to fusion assessment, whichever is sooner.

Exclusion Criteria

• Treated with a bone growth stimulator device other than the SpinalogicTM CMF device.
• Previous cervical vertebrae fusion surgery at any level (posterior or anterior approach)
• Systemic administration of any type of corticosteroid, antineoplastic, immune- stimulating or immunosuppressive agents within 30 days of primary ACDF surgery and/or within 12 weeks post-operatively.
• Active history of systemic malignancy at pre-operative assessment or during 12- month follow up period.
• Untreated malignant neoplasm(s) or underwent radiotherapy or chemotherapy at pre- operative assessment or during 12-month follow up period.
• Implanted with cardiac pacemaker or implantable cardioverter defibrillator at pre- operative assessment or during 12-month follow up period.
• Pregnant at pre-operative assessment or during 12-month follow up period.
• Mental or physical condition that would interfere with post-treatment assessments and/or care (e.g., neuromuscular disease, psychiatric disease,
• Paraplegia, quadriplegia, etc.) at pre-operative assessment or during 12-month follow up period.
• Prescribed non-steroidal anti-inflammatory, calcium channel blockers and/or diphosphonate therapy within 12-weeks of surgery period.
• Prescribed bone morphogenic protein (BMP) during 12-month follow up period.
• Implanted with a Titanium cage during the primary ACDF that precludes an outcome determination via plain radiographs.
• Osseous or ligamentous spinal trauma at pre-operative assessment or during 12- month follow up period.
• Paget's disease at pre-operative assessment or during 12-month follow up period.
• Absence of X-ray fusion assessment documentation at 6 months follow-up visit.