Durability of Supplementary Rod Constructs-SuppleMentAry Rod Technique (SMART)-for Long-segment Posterior Instrumented Spinal Fusion Procedures: A Multicenter Retrospective Comparative Study With Dual-rod Constructs

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Stanford Spine Clinic
RECRUITING
Redwood City
University of California
NOT_YET_RECRUITING
Sacramento
UCSF Spine Center
RECRUITING
San Francisco
Maryland
John Hopkis Hospital
RECRUITING
Baltimore
Minnesota
University of Minnesota Medical Center
RECRUITING
Minneapolis
Missouri
Washington University in St. Louis, School of Medicine
RECRUITING
St Louis
New York
Columbia University / NYP Och Spine Hospital
RECRUITING
New York
Virginia
University of Virginia
RECRUITING
Charlottesville
Other Locations
Canada
University of Calgary Spine
NOT_YET_RECRUITING
Calgary
University of Toronto
RECRUITING
Toronto
China
Duchess of Kent Children's Hospital
RECRUITING
Hong Kong
India
Kothari Medical Centre
RECRUITING
Kolkata
Japan
Hamamatsu University School of Medicine
RECRUITING
Hamamatsu
University of Tokyo
RECRUITING
Tokyo
Spain
Hospital Vall d´Hebron
NOT_YET_RECRUITING
Barcelona
Turkey
Acibadem Maslak Hospital
NOT_YET_RECRUITING
Istanbul
Contact Information
Primary
Aleksandra Hodor
aleksandra.hodor@aofoundation.org
+41 79 369 49 63
Backup
Viola Grünenfelder
viola.gruenenfelder@aofoundation.org
+41 79 696 33 97
Time Frame
Start Date: 2025-03-24
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 1244
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: AO Foundation, AO Spine

This content was sourced from clinicaltrials.gov