A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients
NCT ID: NCT05101057
Last Updated: 2021-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2021-11-15
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Treated
Patients who underwent ACDF surgery and who received post surgical therapy with the SpinalogicTM Non-Invasive Bone Graft Stimulation Device.
SpinalogicTM 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.
Control
Patients who underwent ACDF surgery and did not receive post surgical Bone Graft Stimulation.
No interventions assigned to this group
Interventions
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SpinalogicTM 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Medical Metrics Diagnostics, Inc
INDUSTRY
Encore Medical, L.P.
INDUSTRY
Responsible Party
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Principal Investigators
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Ruba Sarris, MPH
Role: STUDY_DIRECTOR
DJO
Locations
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SIOSD
San Diego, California, United States
BSSNY
White Plains, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Ramin Raiszadeh, MD
Role: primary
Josephine Turner
Role: backup
John Abrahams, MD
Role: primary
Rami Elsabeh
Role: backup
References
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Marquez-Lara A, Nandyala SV, Fineberg SJ, Singh K. Current trends in demographics, practice, and in-hospital outcomes in cervical spine surgery: a national database analysis between 2002 and 2011. Spine (Phila Pa 1976). 2014 Mar 15;39(6):476-81. doi: 10.1097/BRS.0000000000000165.
Eck JC, Hodges SD, Humphreys SC. Techniques for stimulating spinal fusion: efficacy of electricity, ultrasound, and biologic factors in achieving fusion. Am J Orthop (Belle Mead NJ). 2001 Jul;30(7):535-41.
Gruskay JA, Webb ML, Grauer JN. Methods of evaluating lumbar and cervical fusion. Spine J. 2014 Mar 1;14(3):531-9. doi: 10.1016/j.spinee.2013.07.459. Epub 2013 Oct 31.
Veeravagu A, Cole T, Jiang B, Ratliff JK. Revision rates and complication incidence in single- and multilevel anterior cervical discectomy and fusion procedures: an administrative database study. Spine J. 2014 Jul 1;14(7):1125-31. doi: 10.1016/j.spinee.2013.07.474. Epub 2013 Oct 11.
Leven D, Cho SK. Pseudarthrosis of the Cervical Spine: Risk Factors, Diagnosis and Management. Asian Spine J. 2016 Aug;10(4):776-86. doi: 10.4184/asj.2016.10.4.776. Epub 2016 Aug 16.
Hilibrand AS, Fye MA, Emery SE, Palumbo MA, Bohlman HH. Impact of smoking on the outcome of anterior cervical arthrodesis with interbody or strut-grafting. J Bone Joint Surg Am. 2001 May;83(5):668-73. doi: 10.2106/00004623-200105000-00004.
Campbell PG, Yadla S, Nasser R, Malone J, Maltenfort MG, Ratliff JK. Patient comorbidity score predicting the incidence of perioperative complications: assessing the impact of comorbidities on complications in spine surgery. J Neurosurg Spine. 2012 Jan;16(1):37-43. doi: 10.3171/2011.9.SPINE11283. Epub 2011 Oct 28.
Other Identifiers
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PS-608
Identifier Type: -
Identifier Source: org_study_id