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

NCT05696470 | Active Not Recruiting FDA Device

• 1 other identifier: 2020H0309
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiculopathy; Myelopathy Cervical; Foraminal Stenosis; Central Canal Stenosis

Outcome Measures

Primary Outcomes (1)

• Fusion rate

  based on postoperative X-ray: presence of bone trabeculae across graft-host interface, absence of radiolucent gap between graft and adjacent vertebral body, restriction of motion to 2mm or less between adjacent vertebral spinous processes on flexion-extension lateral radiographs

  24 months

Secondary Outcomes (11)

• NRS

  24 months

• NDI

  24 months

• SF36 RAND

  24 months

• Neurological assessment: Upper Extremity Strength

  24 months

• Cervical sagittal alignment

  24 months

Interventions

DePuy Synthes Conduit 3D printed titanium cages DEVICE

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

Eligibility Criteria

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

Study Population

Patients undergoing 3 to 4 level ACDF procedures from C2-T1

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center Neurological Surgery

Columbus, Ohio, 43219, United States

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor Residency Program Director Deformity and Robotic Spinal Fellowship Director

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: January 25, 2023
• Study Start: March 31, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

US (1)