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Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages
Sponsor: Ohio State University
Summary
The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle screw instrumentation, using one of the following interbody cages; the Medtronic Adaptix™ cage with roughened micro and nano-textured titanium surfaces or the CAPSTONE® poly-ether-ether-ketone cage.
Official title: Lumbar Fusion With Micro and Nano-textured Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Adaptix™ Versus PEEK Cages
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2021-11-19
Completion Date
2026-04-01
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Medtronic Adaptix™ titanium implants
Patients who will be having a spinal fusion procedure as part of their standard of care treatment will be randomized to receive either the Medtronic titanium or the PEEK cage supplemented with a pedicle screw system and milled local autograft bone supplemented with GRAFTON DBM DBF. In order to assess fusion, patients will undergo a research-only CT Scan at 6 months post-surgery.
Medtronic CAPSTONE® PEEK cage
Medtronic CAPSTONE® PEEK cage
Locations (1)
The Ohio State University Wexner Medical Center Neurological Surgery
Columbus, Ohio, United States