A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients (NCT05101057) | Clinical Trial Compass
UnknownNot Applicable
A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients
United States400 participantsStarted 2021-11-15
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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…