Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions

Part of paid clinical trials in Redwood City, California.

Sponsor
AO Foundation, AO Spine
Study ID
NCT06368245
Status
Recruiting

Conditions

  • Spinal Fusion

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 24, 2025
Status verified
Mar 2026
Primary completion
Dec 15, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
1,244 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Stanford Spine ClinicRedwood CityCalifornia94588
Serena Hu, MD
University of CaliforniaSacramentoCalifornia95819
Yashar Javidan
UCSF Spine CenterSan FranciscoCalifornia94144
Christopher Ames
John Hopkis HospitalBaltimoreMaryland21287
Khaled Kebaish
University of Minnesota Medical CenterMinneapolisMinnesota55454
David Polly, MD
Washington University in St. Louis, School of MedicineSt LouisMissouri63110
Brian Neuman
Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110St LouisMissouri63310
Munish Gupta
Columbia University / NYP Och Spine HospitalNew YorkNew York10032
Zeeshan Sardar
University of VirginiaCharlottesvilleVirginia22908
Justin S Smith, MD, PhD
434-243-6339
Judith G Beenhakker

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