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| Name | Class |
|---|---|
| Medical Metrics Diagnostics, Inc | INDUSTRY |
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A retrospective parallel group comparison study to support expansion of the indication of the company's FDA approved Spinalogicâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Patients who underwent ACDF surgery and who received post surgical therapy with the SpinalogicTM Non-Invasive Bone Graft Stimulation Device. |
| |
| Control | Patients who underwent ACDF surgery and did not receive post surgical Bone Graft Stimulation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpinalogicTM Bone Graft Stimulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to fusion | Comparison of the cervical fusion rate between treated and control group patients | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome Measures VAS | VAS Pain Score | 12 months |
| Patient Reported Outcome Measures NDI | Neck Disability Index | 12 months |
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Inclusion Criteria
Exclusion Criteria
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Subjects underwent primary anterior cervical discectomy and fusion (ACDF) and required two- level cervical spine fusions. OR were active smokers and required either single or two-level cervical spine fusions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CLAIRE D WILLIAMS, MA | Contact | 19789964243 | Claire.Willams8@djoglobal.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruba Sarris, MPH | DJO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SIOSD | Recruiting | San Diego | California | 92120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24365907 | Background | 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. | |
| 11482508 | Background | 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. |
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| Patient Reported Outcome Measures OC | Odum's Criteria | 12 months |
| BSSNY | Recruiting | White Plains | New York | 10604 | United States |
|
| 24183750 | Background | 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. |
| 24126076 | Background | 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. |
| 27559462 | Background | 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. |
| 11379735 | Background | 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. |
| 22035101 | Background | 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. |