Recruiting

Thoracolumbar Fusion

Sponsor:

AO Foundation, AO Spine

Code:

NCT06368245

Conditions

Spinal Fusion

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

long-segment posterior TL instrumented fusion

Study Details

Brief summary:

This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites.

Conditions

Spinal Fusion

Study ID

NCT06368245

Start date

Mar 24, 2025

Status verified date

Jun, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 45 years and older.
  • Patients receiving long-segment posterior TL instrumented fusion using either supplementary rod constructs or dual-rod constructs (the index surgery).

  • Long-segment is defined as the UIV at a thoracic level and the LIV at the sacrum/ilium.
  • Supplementary rod constructs are defined as: in addition to the traditional two primary rods, at least one supplementary rod (eg, accessory rods or satellite rods) is used, and at least one supplementary rod and one primary rod (ie, at least two rods) together must span multiple (≥ 2) vertebral levels. The supplementary rod constructs do not include rods connected end-to-end or side-to-side that do not bridge multiple vertebral levels.
  • The index surgery can be a primary surgery or a revision surgery.
  • The index surgery, staged or non-staged, must use posterior spinal fusion but can be in combination with other approaches such as an anterior procedure.
  • If the index surgery is a revision surgery, the primary rods must be replaced in the revision surgery, with the exception of Harrington or Luque rods which can remain in place.

o If the Harrington or Luque rods remain in situ, they must already have the UIV at the thoracic level and the LIV at the sacrum/ilium, or an extension of the existing Harrington or Luque is performed such that the UIV is at the thoracic level and the LIV at the sacrum/ilium.
  • The index surgery was performed between January 1, 2014, and December 31, 2020, inclusive.
  • Minimum 3 months of FU after the index surgery.
  • Ability to provide informed consent according to the IRB/EC defined and approved procedures if applicable for retrospective data analysis.

Exclusion Criteria:

  • Spinal fusion performed for acute trauma (ie, ≤ 1 year of trauma).
  • Spinal fusion performed for tumor.
  • Spinal fusion performed for infection.
  • Patients with Parkinson's Disease.
  • Patients with neuromuscular disorders.
  • Patients with spine malignancies requiring chemo- or radiation therapy.

Study Design

Enrollment

1244 participants

Anticipated

Interventions and Outcome Measures

Arms

primary/revision long-segment posterior TL instrumented fusion with dual-rod constructs

The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using dual-rod construct.

primary/revision long-segment posterior TL instrumented fusion with supplementary rod constructs

The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct.

Interventions

long-segment posterior TL instrumented fusion

long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs.

Primary outcome measure

  • Rod fracture (RF) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Alix Frischknecht

+41 79 606 41 48alix.frischknecht@aofoundation.org

Viola Grünenfelder

+41 79 696 33 97viola.gruenenfelder@aofoundation.org

Locations

Stanford Spine Clinic

Recruiting

Redwood City, California, United States, 94588

Contacts

Serena Hu, MD

shu3@stanford.edu

University of California

Recruiting

Sacramento, California, United States, 95819

Contacts

Yashar Javidan

yjavidan@ucdavis.edu

UCSF Spine Center

Recruiting

San Francisco, California, United States, 94144

John Hopkis Hospital

Recruiting

Baltimore, Maryland, United States, 21287

University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

David Polly, MD

pollydw@umn.edu

Washington University in St. Louis, School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Columbia University / NYP Och Spine Hospital

Recruiting

New York, New York, United States, 10032

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Justin S Smith, MD, PhD

434-243-6339jss7f@virginia.edu

Judith G Beenhakker

JGB3P@uvahealth.org

University of Calgary Spine

Recruiting

Calgary, Canada, T2N 2T9

University of Toronto

Recruiting

Toronto, Canada, M5T 2S8

More Information

Sponsor

AO Foundation, AO Spine

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AO Foundation, AO Spine on 2026-06-30.