CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Interbody cage (titanium) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03647501
NCT03647501N/ACompleted
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Lumbar Fusion With 3D-Printed Porous Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Nexxt Matrixx(TM) Versus PEEK Cages

Ohio State University·interventional·Posted Aug 27, 2018·Updated Jun 15, 2023

In Brief

A clinical study evaluating Interbody cage (titanium) and Interbody cage (PEEK) for Lumbar Degenerative Disc Disease and 4 related conditions. Completed, enrolled 53 participants across 1 site.

Detailed 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 Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage or the HonourTM poly-ether-ether-ketone cage.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Lumbar Spinal Deformity, Lumbar Spondylosis
CountriesUnited States
CollaboratorsNexxt Spine, LLC

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 27, 2018
Enrollment StartAug 22, 2018
Primary CompletionMar 16, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.8 years ago

Interventions

Interbody cage (titanium)device

Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.

Interbody cage (PEEK)device

Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.