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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 5, 2018
Sponsor:
Collaborator:
Nexxt Spine, LLC
Information provided by (Responsible Party):
H Francis Farhadi, MD, PhD, Ohio State University

Tracking Information
First Submitted Date  ICMJE August 21, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date September 5, 2018
Actual Study Start Date  ICMJE August 22, 2018
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
Interbody radiographic fusion rate [ Time Frame: 6 months post-operatively ]
Classification of interbody fusion success will be assessed using the Brantigan, Steffee, Fraser (BSF) scale. The subject will be considered a success if fusion is a Grade BSF-3 at 6 months.
Change History Complete list of historical versions of study NCT03647501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages
Official Title  ICMJE Lumbar Fusion With 3D-Printed Porous Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Nexxt Matrixx(TM) Versus PEEK Cages
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Lumbar Degenerative Disc Disease
  • Lumbar Spinal Stenosis
  • Lumbar Spondylolisthesis
  • Lumbar Spinal Deformity
  • Lumbar Spondylosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Interbody cage (titanium)
  • 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.
    Intervention: Device: Interbody cage (PEEK)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2024
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03647501
Other Study ID Numbers  ICMJE 2018H0008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party H Francis Farhadi, MD, PhD, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Nexxt Spine, LLC
Investigators  ICMJE Not Provided
PRS Account Ohio State University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP