NCT06368245

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.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
1,244

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
7 countries

17 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Mar 2025Jul 2029

First Submitted

Initial submission to the registry

March 20, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

March 24, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

March 20, 2024

Last Update Submit

March 2, 2026

Conditions

Spinal Fusion

Outcome Measures

Primary Outcomes (1)

  • Rod fracture (RF)

    Incidence of rod fracture(s)

    2 years

Secondary Outcomes (7)

  • Time to rod fracture

    2 years

  • Time to rod fracture

    10 years and 3 months

  • Configurations of supplementary rod constructs

    Baseline

  • Treatment for rod fracture

    10 years and 3 months

  • Recurrent RFs

    10 years and 3 months

  • +2 more secondary outcomes

Study Arms (2)

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.

Procedure: long-segment posterior TL instrumented fusion

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.

Procedure: long-segment posterior TL instrumented fusion

Interventions

long-segment posterior TL instrumented fusionPROCEDURE

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

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

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent long-segment posterior thoracolumbar (TL) instrumented fusion

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Stanford Spine Clinic

Redwood City, California, 94588, United States

RECRUITING

University of California

Sacramento, California, 95819, United States

RECRUITING

UCSF Spine Center

San Francisco, California, 94144, United States

RECRUITING

John Hopkis Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

University of Minnesota Medical Center

Minneapolis, Minnesota, 55454, United States

RECRUITING

Washington University in St. Louis, School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110

St Louis, Missouri, 63310, United States

RECRUITING

Columbia University / NYP Och Spine Hospital

New York, New York, 10032, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

University of Calgary Spine

Calgary, T2N 2T9, Canada

RECRUITING

University of Toronto

Toronto, M5T 2S8, Canada

RECRUITING

Duchess of Kent Children's Hospital

Hong Kong, China

RECRUITING

Kothari Medical Centre

Kolkata, India

RECRUITING

Hamamatsu University School of Medicine

Hamamatsu, 431-3192, Japan

RECRUITING

University of Tokyo

Tokyo, 113-8654, Japan

RECRUITING

Hospital Vall d´Hebron

Barcelona, 08035, Spain

RECRUITING

Acibadem Maslak Hospital

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

Study Officials

  • Justin S Smith, MD, PhD

    Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alix Frischknecht

CONTACT

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

Viola Grünenfelder

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2024

First Posted

April 16, 2024

Study Start

March 24, 2025

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

July 31, 2029

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

IN(1)TU(1)US(9)CN(1)CA(2)JP(2)ES(1)