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

Status Completed

Clinical Trial 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.

Clinical Trial Description

This randomized controlled trial will prospectively evaluate the safety and efficacy of the Nexxt MatrixxTM System titanium implant supplemented with a pedicle screw system as compared to a representative PEEK cage currently used in routine fashion for lumbar interbody fusion procedures. This study will capture clinical and radiographic outcomes on patients up to 2 years post operatively. Both cages will be used in conjunction with milled local autograft bone generated as part of the spinal fusion procedure (no iliac crest autograft will be utilized). This single centered study will enroll up to 70 subjects (n = 35 per group), with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for combined interbody/posterolateral lumbar fusion surgery. Subjects will be randomized in the trial to receive either the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage or the HonourTM PEEK cage supplemented with a pedicle screw system and milled local autograft bone. Subject randomization will be stratified according to smoking status. Subjects will be blinded to their group status for the duration of the study assessments and procedures (24 months post-operatively). Subject study data will be collected preoperatively, intra-operatively and postoperatively at 3, 6, 12, and 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03647501
Study type	Interventional
Source	Ohio State University
Contact
Status	Completed
Phase	N/A
Start date	August 22, 2018
Completion date	March 16, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.