Clinical trial NCT05945550: Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?
Official title: Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lumbar Spondylolisthesis
Lumbar Spine Degeneration
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 17 years of age, patients having had ALIF procedures as defined by CPT codes at participating Methodist facilities during 2010-2020 targeted.

Brief summary: To identify the current mortality rate for initial ALIF procedures. Establish/prove mortality rates for this operation have dropped in the past decade.

Detailed description: Establish the mortality rate for "re-do" ALIF procedures \[i.e., is it different than that of initial ALIF procedures and - if so - postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk. This study is not designed to "prove" the latter hypothesis.\]

This 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.

Eligibility criteria: Inclusion Criteria:

* Patients \> 17 years of age, patients having had ALIF procedures as defined by CPT codes at participating Methodist facilities during 2010-2020 targeted.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Establish/prove mortality rates
timeFrame: 5 years
Secondary outcomes:
measure: Establish the mortality rate for "re-do" ALIF procedures [
timeFrame: 5 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Reed Donald, MD
role: PRINCIPAL_INVESTIGATOR
References:
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/
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/
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.
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.
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.
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
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.
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