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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Radiculopathy; Myelopathy Cervical; Foraminal Stenosis; Central Canal Stenosis
• Intervention / Treatment: Device: DePuy Synthes Conduit 3D printed titanium 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.

• Study Type: Observational
• Enrollment (Estimated): 58

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43219
      • The Ohio State University Wexner Medical Center Neurological Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS	Numeric Rating Scale for neck and arm pain	24 months
NDI	Neck Disability Index	24 months
SF36 RAND	Short Form 36 RAND	24 months
Neurological assessment: Upper Extremity Strength	grip, biceps, triceps, delts, intrinsics, wrist extrinsic) measured on scale of 0-5 follwing INSCI assessment for Manual Muscle Testing (MMT)	24 months
Cervical sagittal alignment	Standing radiographs of the sagittal spine to identify changes in functional sagittal; will measure the Cobb angle between the lower endplate of C2 and C7 (C2L-C7L angle) alignment after cervical fusion as determined by functional segments between cervicothoracic and thoracolumbar. Patient cervical 4 view x-rays pre-operatively and at follow-ups will be compared.	24 months
Reoperation	Reoperation at cervical and thoracic levels while patient is enrolled in the study. Hardware removed, new hardware added	24 months
number of days in the hospital	number of days in the hospital	up to 24 months
Adverse events	wound infection, dysphagia, hematoma, dysphonia, DVT, etc	24 months
Neurological assessment: Sensory function (C2-C7 dermatome)	Pin prick sensation is assessed with a needle. Light touch sensation is assessed with a piece of tissue paper.	24 months
Neurological assessment: Sensation is scored as absent (0), abnormal (1), or normal (2)	Reflexes (Biceps, Brachioradials, Triceps)-Upper and lower extremities should be examined for asymmetry in deep tendon reflexes.	24 months
Neurological assessment: Hoffman's and Spurlings	Testing for positive or negative indication	24 months

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Constriction, Pathologic; Spinal Cord Diseases
• Other Study ID Numbers: 2020H0309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes