Degeneration of Cervical Intervertebral Disc
Conditions
Brief 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.
Interventions
DEVICESpinalogicTM Bone Graft Stimulator
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.
Sponsors
Medical Metrics Diagnostics, Inc
Encore Medical, L.P.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to fusion | 12 months | Comparison of the cervical fusion rate between treated and control group patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Measures VAS | 12 months | VAS Pain Score |
| Patient Reported Outcome Measures NDI | 12 months | Neck Disability Index |
| Patient Reported Outcome Measures OC | 12 months | Odum's Criteria |
Countries
United States
Contacts
Primary ContactCLAIRE D WILLIAMS, MA
Outcome results
None listed