Clinical trial NCT03647501: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Degenerative Disc Disease
Lumbar Spinal Stenosis
Lumbar Spondylolisthesis
Lumbar Spinal Deformity
Lumbar Spondylosis
Keywords: lumbar spinal arthrodesis
interbody cage
3D-printing
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nexxt Spine, LLC
First posted: 2018-08-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Interbody Radiographic Fusion Rate
timeFrame: 6 months post-operatively
Secondary outcomes:
measure: Post-operative Timing of Fusion
timeFrame: 12 months post-operatively
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Shelby Miracle
state: Ohio
Study officials:
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