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

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.

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.