N/A
N=53
Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages
Lumbar Degenerative Disc Disease · Lumbar Spinal Stenosis · Lumbar Spondylolisthesis · Lumbar Spinal Deformity · Lumbar Spondylosis
Bottom Line
View on ClinicalTrials.gov: NCT03647501 ↗Enrolled (actual)
53
Serious AEs
24.5%
Results posted
Jun 2023
Primary outcome: Primary: Interbody Radiographic Fusion Rate — 27; 10; 6; 24 Cages/Spinal Levels
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interbody cage (titanium) (Device); Interbody cage (PEEK) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interbody Radiographic Fusion Rate |
27; 10; 6; 24; 0; 6 | — |
| SECONDARY Post-operative Timing of Fusion |
5; 12; 19; 17 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03647501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.