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

Study Overview
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Brief Summary
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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.

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

Conditions
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Degeneration of Cervical Intervertebral Disc

Intervention / Treatment
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* Device: SpinalogicTM Bone Graft Stimulator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated<br>Patients who underwent ACDF surgery and who received post surgical therapy with the SpinalogicTM Non-Invasive Bone Graft Stimulation Device. | Device: SpinalogicTM Bone Graft Stimulator<br>* 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.<br>|
| Control<br>Patients who underwent ACDF surgery and did not receive post surgical Bone Graft Stimulation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fusion | Comparison of the cervical fusion rate between treated and control group patients | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome Measures VAS | VAS Pain Score | 12 months | 
| Patient Reported Outcome Measures NDI | Neck Disability Index | 12 months | 
| Patient Reported Outcome Measures OC | Odum's Criteria | 12 months |