Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?

Lumbar Spondylolisthesis Clinical Trial

Official title:

Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05945550
• Other study ID #: 038.SUR.2020.A
• Status: Active, not recruiting
• Start date: December 28, 2020
• Est. completion date: December 28, 2024

Study information

• Verified date: November 2023
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3500
• Est. completion date: December 28, 2024
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Spine Degeneration
• Lumbar Spondylolisthesis
• Spondylolisthesis

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

References & Publications (8)

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/

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.

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

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

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. — View 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. — View 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. — View 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish/prove mortality rates	Establish mortality rates of patients for this operation have dropped in the past decade.	5 years
Secondary	Establish the mortality rate for "re-do" ALIF procedures [	Establish the patient's mortality rate, postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk.	5 years