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

Primary Purpose

Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Interbody cage (titanium)

Interbody cage (PEEK)

About this trial

This is an interventional treatment trial for Lumbar Degenerative Disc Disease focused on measuring lumbar spinal arthrodesis, interbody cage, 3D-printing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shelby Miracle

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

3D-printed titanium cage

Poly-ether-ether-ketone (PEEK) cage

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Interbody Radiographic Fusion Rate

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 where a higher score indicates a better outcome. The grades are defined as follows: Brantigan, Steffee, Fraser-Grade 1 (BSF-1) indicates radiographical pseudarthrosis, Brantigan, Steffee, Fraser-Grade 2 (BSF-2) is defined by radiographical locked pseudarthrosis, and Brantigan, Steffee, Fraser-Grade 3 (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

Post-operative Timing of Fusion

Secondary measures of effectiveness will be determined by timing of fusion observed in X-rays post-operatively. Fusion at one year was defined as a difference in cobb angle of the operated levels between flexion and extension views. More than 2 degrees of change between views indicated non-union at one year.

Full Information

NCT ID

NCT03647501

First Posted

August 21, 2018

Last Updated

May 22, 2023

Sponsor

Ohio State University

Collaborators

Nexxt Spine, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03647501

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

August 22, 2018 (Actual)

Primary Completion Date

March 16, 2022 (Actual)

Study Completion Date

March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University

Collaborators

Nexxt Spine, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

lumbar spinal arthrodesis, interbody cage, 3D-printing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Participant

Masking Description

Subjects will be blinded to their group status for the duration of the study assessments and procedures (up to 24 months post-operatively).

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3D-printed titanium cage

Arm Type

Active Comparator

Arm Description

Arm Title

Poly-ether-ether-ketone (PEEK) cage

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Interbody cage (titanium)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Interbody cage (PEEK)

Intervention Description

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

Primary Outcome Measure Information:

Title

Interbody Radiographic Fusion Rate

Description

Time Frame

6 months post-operatively

Secondary Outcome Measure Information:

Title

Post-operative Timing of Fusion

Description

Time Frame

12 months post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Shelby Miracle

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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