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ACTIVE NOT RECRUITING
NCT05182489
NA

Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

Sponsor: Ohio State University

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

Medtronic CAPSTONE® PEEK cage

Medtronic CAPSTONE® PEEK cage

Locations (1)

The Ohio State University Wexner Medical Center Neurological Surgery

Columbus, Ohio, United States