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

NCT03647501 | Completed Results FDA Device

• 1 other identifier: 2018H0008
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Degenerative Disc Disease; Lumbar Spinal Stenosis; Lumbar Spondylolisthesis; Lumbar Spinal Deformity; Lumbar Spondylosis

Keywords

lumbar spinal arthrodesis; interbody cage; 3D-printing

Outcome Measures

Primary Outcomes (1)

• Interbody Radiographic Fusion Rate

  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 where a higher score indicates a better outcome. The grades are defined as follows: Brantigan, Steffee, Fraser-Grade 1 (BSF-1) indicates radiographical pseudarthrosis, Brantigan, Steffee, Fraser-Grade 2 (BSF-2) is defined by radiographical locked pseudarthrosis, and Brantigan, Steffee, Fraser-Grade 3 (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.

  6 months post-operatively

Secondary Outcomes (1)

• Post-operative Timing of Fusion

  12 months post-operatively

Study Arms (2)

3D-printed titanium cage

ACTIVE COMPARATOR

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)

Poly-ether-ether-ketone (PEEK) cage

ACTIVE COMPARATOR

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)

Interventions

Interbody cage (titanium) DEVICE

Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.

3D-printed titanium cage

Interbody cage (PEEK) DEVICE

Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.

Poly-ether-ether-ketone (PEEK) cage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Nexxt Spine, LLC: collaborator

Study Sites (1)

Shelby Miracle

Columbus, Ohio, 43210, United States

Location

Related Publications (19)

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  PMID: 37542447 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis; Spondylosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis

Results Point of Contact

• Title: Shelby Miracle
• Organization: The Ohio State University

shelby.miracle@osumc.edu

614-366-1648

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to their group status for the duration of the study assessments and procedures (up to 24 months post-operatively).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurological Surgery

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 27, 2018
• Study Start: August 22, 2018
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)