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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT03647501
• Date of registration: 21/08/2018
• Prospective Registration: Yes
• Primary sponsor: Ohio State University
• Public title: Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages
• Scientific title: Lumbar Fusion With 3D-Printed Porous Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Nexxt Matrixx(TM) Versus PEEK Cages
• Date of first enrolment: August 22, 2018
• Target sample size: 70
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03647501
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Andrea Hesse, B.S.

• Name: Andrea Hesse, B.S.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lumbar Degenerative Disc Disease

Lumbar Spondylosis

Lumbar Spinal Deformity

Lumbar Spondylolisthesis

Lumbar Spinal Stenosis

Intervention(s)

Device: Interbody cage (titanium)

Device: Interbody cage (PEEK)

Primary Outcome(s)

Interbody radiographic fusion rate [Time Frame: 6 months post-operatively]

Secondary Outcome(s)

Post-operative timing of fusion [Time Frame: 3, 6, 12, and 24 months post-operatively]

Secondary ID(s)

2018H0008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nexxt Spine, LLC