Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs

NCT ID: NCT05696470

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2026-12-31

Brief Summary

The purpose of this trial is to assess fusion rates in 3 and 4 level ACDFs in patients implanted with DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM. This will be a non-inferiority study, looking to show that Synthes Conduit 3D printed titanium cages fuse as well as cages.

Detailed Description

This is a prospective, single arm study of clinical and radiological outcomes from anterior cervical discectomy and fusions for cervical spondylosis. 58 Patients undergoing 3 to 4 level ACDF procedures from C2-T1 will be enrolled. Patients will be implanted with DePuy Conduit Titanium ACDF cage (DePuy Synthes, Raynham, MA). A retrospective comparision group will be used. The retrospective group will include 58 consecutive patients undergoing 3-4 level ACDFs with milled allograft.

This single-centered study will enroll up to 58 subjects, with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for three or four level anterior cervical fusion surgeries. The inclusion/exclusion criteria are listed below.

Conditions

Radiculopathy; Myelopathy Cervical; Foraminal Stenosis; Central Canal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

DePuy Synthes Conduit 3D printed titanium cages

DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years old
• Symptomatic multi-level degenerative cervical spondylosis necessitating anterior cervical arthrodesis in the subaxial cervical spine (between C2-T1).
• Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
• Cervical x-rays at 24 months (±60 days; retrospective comparison group only)

Exclusion Criteria

• Traumatic spinal fractures or spinal cord injury
• Previous cervical fusion surgery
• Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator
• Severe co-morbidities (e.g., heart, respiratory, or renal disease)
• Recent (<3 yrs) or co-incident spinal tumor or infection
• Concurrent involvement in another investigational drug or device study that could confound study data (prospective exclusion only)
• History of substance abuse (recreational drugs, prescription drugs or alcohol) that could 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 24 months
• Prisoner
• Other contraindications for DePuy Conduit 3D printed titanium cage implant (prospective exclusion only)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Grossbach

Assistant Clinical Professor Residency Program Director Deformity and Robotic Spinal Fellowship Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University Wexner Medical Center Neurological Surgery

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2020H0309

Identifier Type: -

Identifier Source: org_study_id