Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 5:25 PM
Study NCT ID:
NCT05101057
Status:
UNKNOWN
Last Update Posted:
2021-12-07
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-06', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-10-19', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to fusion', 'timeFrame': '12 months', 'description': 'Comparison of the cervical fusion rate between treated and control group patients'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcome Measures VAS', 'timeFrame': '12 months', 'description': 'VAS Pain Score'}, {'measure': 'Patient Reported Outcome Measures NDI', 'timeFrame': '12 months', 'description': 'Neck Disability Index'}, {'measure': 'Patient Reported Outcome Measures OC', 'timeFrame': '12 months', 'description': "Odum's Criteria"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Degeneration of Cervical Intervertebral Disc']}, 'referencesModule': {'references': [{'pmid': '24365907', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11482508', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24183750', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24126076', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27559462', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11379735', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22035101', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Male or Female aged 18-75 years.\n* 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.\n* Pain VAS score \\>5 and/or extreme weakness at target operative level(s).\n* At least one post operative clinical outcome assessment (VAS pain/ NDI/OC score) at each follow up interval.\n* Completed 6 month follow up visit or time to fusion assessment, whichever is sooner.\n\nExclusion Criteria\n\n* Treated with a bone growth stimulator device other than the SpinalogicTM CMF device.\n* Previous cervical vertebrae fusion surgery at any level (posterior or anterior approach)\n* 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.\n* Active history of systemic malignancy at pre-operative assessment or during 12- month follow up period.\n* Untreated malignant neoplasm(s) or underwent radiotherapy or chemotherapy at pre- operative assessment or during 12-month follow up period.\n* Implanted with cardiac pacemaker or implantable cardioverter defibrillator at pre- operative assessment or during 12-month follow up period.\n* Pregnant at pre-operative assessment or during 12-month follow up period.\n* Mental or physical condition that would interfere with post-treatment assessments and/or care (e.g., neuromuscular disease, psychiatric disease,\n* Paraplegia, quadriplegia, etc.) at pre-operative assessment or during 12-month follow up period.\n* Prescribed non-steroidal anti-inflammatory, calcium channel blockers and/or diphosphonate therapy within 12-weeks of surgery period.\n* Prescribed bone morphogenic protein (BMP) during 12-month follow up period.\n* Implanted with a Titanium cage during the primary ACDF that precludes an outcome determination via plain radiographs.\n* Osseous or ligamentous spinal trauma at pre-operative assessment or during 12- month follow up period.\n* Paget's disease at pre-operative assessment or during 12-month follow up period.\n* Absence of X-ray fusion assessment documentation at 6 months follow-up visit."}, 'identificationModule': {'nctId': 'NCT05101057', 'briefTitle': 'A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Encore Medical, L.P.'}, 'officialTitle': 'A Retrospective Study to Examine the Effect of Adjuvant Combined Magnetic Field Stimulation on Primary Anterior Cervical Discectomy and Fusion (ACDF) Patients', 'orgStudyIdInfo': {'id': 'PS-608'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treated', 'description': 'Patients who underwent ACDF surgery and who received post surgical therapy with the SpinalogicTM Non-Invasive Bone Graft Stimulation Device.', 'interventionNames': ['Device: SpinalogicTM Bone Graft Stimulator']}, {'label': 'Control', 'description': 'Patients who underwent ACDF surgery and did not receive post surgical Bone Graft Stimulation.'}], 'interventions': [{'name': 'SpinalogicTM Bone Graft Stimulator', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92120', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ramin Raiszadeh, MD', 'role': 'CONTACT', 'email': 'ramin@siosd.com', 'phone': '619-265-7912'}, {'name': 'Josephine Turner', 'role': 'CONTACT'}], 'facility': 'SIOSD', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '10604', 'city': 'White Plains', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Abrahams, MD', 'role': 'CONTACT', 'email': 'jabrahams@bssny.com', 'phone': '914-345-8111'}, {'name': 'Rami Elsabeh', 'role': 'CONTACT', 'email': 'relsabeh@bssny.com', 'phone': '19143458111', 'phoneExt': '7909'}], 'facility': 'BSSNY', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}], 'centralContacts': [{'name': 'CLAIRE D WILLIAMS, MA', 'role': 'CONTACT', 'email': 'Claire.Willams8@djoglobal.com', 'phone': '19789964243'}], 'overallOfficials': [{'name': 'Ruba Sarris, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'DJO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Encore Medical, L.P.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medical Metrics Diagnostics, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}