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NCT Number: NCT05696470

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Radiculopathy Central Canal Stenosis Foraminal Stenosis Myelopathy Cervical Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center Neurological Surgery

Columbus, Ohio, 43219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Fusion rate

    Time frame: 24 months

    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

Secondary outcomes

  1. NRS

    Time frame: 24 months

    Numeric Rating Scale for neck and arm pain

  2. NDI

    Time frame: 24 months

    Neck Disability Index

  3. SF36 RAND

    Time frame: 24 months

    Short Form 36 RAND

  4. Neurological assessment: Upper Extremity Strength

    Time frame: 24 months

    grip, biceps, triceps, delts, intrinsics, wrist extrinsic) measured on scale of 0-5 follwing INSCI assessment for Manual Muscle Testing (MMT)

  5. Cervical sagittal alignment

    Time frame: 24 months

    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.

  6. Reoperation

    Time frame: 24 months

    Reoperation at cervical and thoracic levels while patient is enrolled in the study. Hardware removed, new hardware added

  7. number of days in the hospital

    Time frame: up to 24 months

    number of days in the hospital

  8. Adverse events

    Time frame: 24 months

    wound infection, dysphagia, hematoma, dysphonia, DVT, etc

  9. Neurological assessment: Sensory function (C2-C7 dermatome)

    Time frame: 24 months

    Pin prick sensation is assessed with a needle. Light touch sensation is assessed with a piece of tissue paper.

  10. Neurological assessment: Sensation is scored as absent (0), abnormal (1), or normal (2)

    Time frame: 24 months

    Reflexes (Biceps, Brachioradials, Triceps)-Upper and lower extremities should be examined for asymmetry in deep tendon reflexes.

  11. Neurological assessment: Hoffman's and Spurlings

    Time frame: 24 months

    Testing for positive or negative indication

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2023
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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