Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-31 @ 2:06 AM
Study NCT ID:
NCT05945550
Status:
UNKNOWN
Last Update Posted:
2023-11-15
First Post:
2023-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish/prove mortality rates', 'timeFrame': '5 years', 'description': 'Establish mortality rates of patients for this operation have dropped in the past decade.'}], 'secondaryOutcomes': [{'measure': 'Establish the mortality rate for "re-do" ALIF procedures [', 'timeFrame': '5 years', 'description': "Establish the patient's mortality rate, postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spondylolisthesis', 'Lumbar Spine Degeneration']}, 'referencesModule': {'references': [{'pmid': '24851286', 'type': 'BACKGROUND', 'citation': 'Weiss AJ, Elixhauser A. Trends in Operating Room Procedures in U.S. Hospitals, 2001-2011. 2014 Mar. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #171. Available from http://www.ncbi.nlm.nih.gov/books/NBK201926/'}, {'type': 'BACKGROUND', 'citation': '2. NA. (2019). Data on Spinal Fusion Surgery. Retrieved from HealthTrust: The Source Magazine: https://healthtrustpg.com/thesource/clinical-connection/data-on-spinal-fusion-surgery/'}, {'pmid': '30074971', 'type': 'BACKGROUND', 'citation': 'Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.'}, {'pmid': '32652276', 'type': 'BACKGROUND', 'citation': 'Neifert SN, Martini ML, Hanss K, Rothrock RJ, Gilligan J, Zimering J, Caridi JM, Oermann EK. Large Rises in Thoracolumbar Fusions by 2040: A Cause for Concern with an Increasingly Elderly Surgical Population. World Neurosurg. 2020 Dec;144:e25-e33. doi: 10.1016/j.wneu.2020.06.241. Epub 2020 Jul 9.'}, {'type': 'BACKGROUND', 'citation': "5. Ito, H., Tsuchiya, J., & Asami, G. (1934). A New Radical Operation for Pott's Disease. The Journal of Bone and Joint Surgery, 16(3), 499-515."}, {'type': 'BACKGROUND', 'citation': "6. O'Brien, M. F., Kirby, R. P., Hoyle, R. M., & Hostin, R. (2015). Anterior Access to the Thoracic and Lumbar Spine. In R. W. Hald, F. J. Schwab, C. I. Shaffrey, & J. A. Youssef, Global Spinal Alignment (pp. 499-509). St. Louis, Missouri: Quality Medical Publishing, Inc"}, {'pmid': '27669042', 'type': 'BACKGROUND', 'citation': 'Phan K, Xu J, Scherman DB, Rao PJ, Mobbs RJ. Anterior Lumbar Interbody Fusion With and Without an "Access Surgeon": A Systematic Review and Meta-analysis. Spine (Phila Pa 1976). 2017 May 15;42(10):E592-E601. doi: 10.1097/BRS.0000000000001905.'}, {'type': 'BACKGROUND', 'citation': '8. Condon, A. (2019, October 29). Beckers Spine Review. Retrieved from Healthgrades: https://www.beckersspine.com/spine/item/47316-healthgrades-100-best-hospitals-for-spine-surgery-in-the-us.html'}]}, 'descriptionModule': {'briefSummary': 'To identify the current mortality rate for initial ALIF procedures. Establish/prove mortality rates for this operation have dropped in the past decade.', 'detailedDescription': 'Establish the mortality rate for "re-do" ALIF procedures \\[i.e., is it different than that of initial ALIF procedures and - if so - postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk. This study is not designed to "prove" the latter hypothesis.\\]\n\nThis is a single sample study where medical records will be searched by CPT codes for ALIF codes (e.g. 22558, 22585, 22845, etc.) by trained researcher(s) at participating Methodist facilities going back 5-10 years to see if 1500-3500 cases can be identified within that time period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients \\> 17 years of age, patients having had ALIF procedures as defined by CPT codes at participating Methodist facilities during 2010-2020 targeted.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 17 years of age, patients having had ALIF procedures as defined by CPT codes at participating Methodist facilities during 2010-2020 targeted.\n\nExclusion Criteria:\n\n* Pediatric patients (as defined by age \\<18 years old), pregnant women and incarcerated individuals. We do not anticipate any of these in an elective spine surgery group of patients. If they have emergency spine surgery it is normally not an ALIF.'}, 'identificationModule': {'nctId': 'NCT05945550', 'briefTitle': 'Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?', 'orgStudyIdInfo': {'id': '038.SUR.2020.A'}}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Dallas Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Reed Donald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Methodist Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}