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Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages

NCT03647501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2023-06-15

Study results available
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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.

Conditions

  • Lumbar Degenerative Disc Disease
  • Lumbar Spinal Stenosis
  • Lumbar Spondylolisthesis
  • Lumbar Spinal Deformity
  • Lumbar Spondylosis

Interventions

DEVICE

Interbody cage (titanium)

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

DEVICE

Interbody cage (PEEK)

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

Sponsors & Collaborators

  • Nexxt Spine, LLC

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2022-03-16
Completion
2022-03-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03647501 on ClinicalTrials.gov