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

Sponsor

Ohio State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03647501

Collaborator

Nexxt Spine, LLC (Other)

Enrollment

Location

Arms

72.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

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)	N/A

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 Design

Study Type:

Interventional

Anticipated 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.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 :

Aug 22, 2018

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Interbody radiographic fusion rate [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

Post-operative timing of fusion [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.