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NCT04073563 · ClinicalTrials.gov registry record · NA
Transforaminal Lumbar Interbody Fusion (TLIF)
A NA study of Degenerative Disease of the Lumbosacral Spine, sponsored by Medtronic Spinal and Biologics.
- Active
- Registry status
- NA
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT04073563 is a NA study of Degenerative Disease of the Lumbosacral Spine that is active but no longer recruiting, run by Medtronic Spinal and Biologics. The registered enrollment target is 600 participants. The trial reports 20 study locations across 8 states.
The verdict
NCT04073563, a NA study of Degenerative Disease of the Lumbosacral Spine, is active but no longer recruiting, sponsored by Medtronic Spinal and Biologics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively. Overall a maximum of 600 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of Infuse™ in Transforaminal Lumbar Interbody Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.
Conditions Studied
Interventions
- DEVICE Infuse™ Bone Graft (Infuse™)
- DEVICE Intervertebral body fusion device and Medtronic posterior Fixation Systems
Study Locations (20)
Florida
- Advent Health Altamonte Springs - Altamonte Springs
- Mayo Clinic - Jacksonville
- Advent Health Orlando - Orlando
- Orlando Health - Orlando
- Foundation for Orthopaedic Research and Education - Tampa
California
- University of California Irvine - Irvine
- Memorial Health Services - Laguna Hills
- Cedars Sinai Spine Center - Los Angeles
- University of California Davis Medical Center - Sacramento
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
- Boulder Neurosurgical Associates and Justin Parker Neurological Institute/E. Lee Nelson - Boulder
- Vail-Summit Orthopaedics and Neurosurgery - Vail
Indiana
- Goodman Campbell Brain and Spine - Carmel
- Indiana Spine Group - Carmel
- OrthoIndy Northwest Office - Indianapolis
Arizona
- Mayo Clinic - Phoenix
- University of Arizona - Tucson
Connecticut
- Hartford Hospital - Hartford
Illinois
- Rush University Medical Center - Chicago
Iowa
- University of Iowa Hospitals and Clinic - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2028-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04073563
The ClinicalTrials.gov registry entry for NCT04073563 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Spinal and Biologics, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Degenerative Disease of the Lumbosacral Spine appearing as the primary indexed condition, and to 2 interventions - of which Infuse™ Bone Graft (Infuse™) is the first listed.
NCT04073563 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04073563 about?
NCT04073563 is a clinical study titled "Transforaminal Lumbar Interbody Fusion (TLIF)". This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively. Overall a maximum of 600 subje...
What is the current status of trial NCT04073563?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 600 participants. The study started on 2019-12-19. Estimated completion is 2028-07.
What conditions does trial NCT04073563 study?
This clinical trial studies the following conditions: Degenerative Disease of the Lumbosacral Spine.
What interventions are being tested in trial NCT04073563?
The interventions under investigation include: Infuse™ Bone Graft (Infuse™) (DEVICE), Intervertebral body fusion device and Medtronic posterior Fixation Systems (DEVICE).
Who is sponsoring clinical trial NCT04073563?
This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04073563 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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