NCT05945550

Brief Summary

To identify the current mortality rate for initial Anterior Lumbar Interbody Fusion(ALIF)procedures. Establish/prove mortality rates for this operation have dropped in the past decade.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Dec 2020Dec 2028

Study Start

First participant enrolled

December 28, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2028

Last Updated

March 20, 2026

Status Verified

January 1, 2026

Enrollment Period

7 years

First QC Date

July 6, 2023

Last Update Submit

March 18, 2026

Conditions

Lumbar SpondylolisthesisLumbar Spine Degeneration

Outcome Measures

Primary Outcomes (1)

  • Establish/prove mortality rates

    Establish mortality rates of patients for this operation have dropped in the past decade.

    5 years

Secondary Outcomes (1)

  • Establish the mortality rate for "re-do" ALIF procedures [

    5 years

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Related Publications (8)

  • 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/

    PMID: 24851286BACKGROUND

  • 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/

    BACKGROUND

  • 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: 30074971BACKGROUND

  • 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.

    PMID: 32652276BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 27669042BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Reed Donald, MD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 14, 2023

Study Start

December 28, 2020

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

December 28, 2028

Last Updated

March 20, 2026

Record last verified: 2026-01

Locations

US(1)