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

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ClinicalTrials.gov Identifier: NCT03647501
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Nexxt Spine, LLC
Information provided by (Responsible Party):
H Francis Farhadi, MD, PhD, Ohio State University

Brief 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.

Condition or disease Intervention/treatment Phase
Lumbar Degenerative Disc Disease Lumbar Spinal Stenosis Lumbar Spondylolisthesis Lumbar Spinal Deformity Lumbar Spondylosis Device: Interbody cage (titanium) Device: Interbody cage (PEEK) Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All 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.
Masking: Single (Participant)
Masking Description: Subjects will be blinded to their group status for the duration of the study assessments and procedures (24 months post-operatively).
Primary Purpose: Treatment
Official Title: Lumbar Fusion With 3D-Printed Porous Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Nexxt Matrixx(TM) Versus PEEK Cages
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 3D-printed titanium cage
Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Device: Interbody cage (titanium)
Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.

Active Comparator: Poly-ether-ether-ketone (PEEK) cage
Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Device: Interbody cage (PEEK)
Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.




Primary Outcome Measures :
  1. Interbody radiographic fusion rate [ Time Frame: 6 months post-operatively ]
    Interbody fusion will be graded using the Brantigan, Steffee, Fraser (BSF) scale which classifies fusion between the interbody cage and adjacent bone on a scale of 1-3. BSF-1 indicates radiographical pseudarthrosis, BSF-2 is defined by radiographical locked pseudarthrosis, and BSF-3 is radiographical fusion, indicating the best outcome. The subject will be considered a success if fusion is a Grade BSF-3 at 6 months.


Secondary Outcome Measures :
  1. Post-operative timing of fusion [ Time Frame: 3, 6, 12, and 24 months post-operatively ]
    Secondary measures of effectiveness will be determined by timing of fusion observed in X-rays post-operatively.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the Nexxt MatrixxTM 3D-printed titanium cage or HonourTM PEEK cage in conjunction with local autograft bone, and supplementation with a pedicle screw system.
  • Subject must be over the age of 18 years old.
  • Subject has been unresponsive to conservative care for a minimum of 6 months.
  • The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.

Exclusion Criteria:

  • Subjects with previous lumbar arthrodesis surgery.
  • Subjects requiring additional bone grafting materials other than local autograft bone.
  • Subject has inadequate tissue coverage over the operative site.
  • Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
  • Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
  • Subject has an active local or systemic infection.
  • Subject has a metal sensitivity/foreign body sensitivity.
  • Subject is morbidly obese, defined as a body mass index (BMI) greater than 40.
  • Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
  • Subject is currently involved in another investigational drug or device study that could confound study data.
  • Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
  • Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating.
  • Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
  • Subject is a prisoner.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647501


Contacts
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Contact: Andrea Hesse, B.S. 614-688-6412 andrea.hesse@osumc.edu
Contact: Amy J Minnema, M.S. 614-685-9827 amy.minnema@osumc.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Andrea Hesse, B.S.    614-688-6412    andrea.hesse@osumc.edu   
Contact: Amy J Minnema, M.S.    6146859827    amy.minnema@osumc.edu   
Principal Investigator: H Francis Farhadi, MD, PhD         
Sponsors and Collaborators
Ohio State University
Nexxt Spine, LLC

Publications:
Millennium Research Group (MRG) US Markets for Spinal Implants 2013

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Responsible Party: H Francis Farhadi, MD, PhD, Assistant Professor, Department of Neurological Surgery, Ohio State University
ClinicalTrials.gov Identifier: NCT03647501     History of Changes
Other Study ID Numbers: 2018H0008
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by H Francis Farhadi, MD, PhD, Ohio State University:
lumbar spinal arthrodesis
interbody cage
3D-printing
Additional relevant MeSH terms:
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Spondylolysis
Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Ether
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs