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RadiculopathyNCT05696470

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

An observational study of Radiculopathy and Myelopathy Cervical, run by Ohio State University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DePuy Synthes Conduit 3D printed titanium cages
Type of treatment
Medical device
How many people
58 participants
Where
1 siteUnited States
Study dates
31 Mar 2021to 31 Dec 2026
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • ≥ 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)

Who cannot join

  • 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)
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University Wexner Medical Center Neurological Surgery

    Columbus, Ohio, 43219

Other trials in United States

About this study

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.

Read the 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.

Being tested
DePuy Synthes Conduit 3D printed titanium cages
Medical subject headings
Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DePuy Synthes Conduit 3D printed titanium cagesDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

Secondary outcomes (11)

  1. NRS

    Numeric Rating Scale for neck and arm pain

    Measured: 24 months

  2. NDI

    Neck Disability Index

    Measured: 24 months

  3. SF36 RAND

    Short Form 36 RAND

    Measured: 24 months

  4. 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)

    Measured: 24 months

  5. 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.

    Measured: 24 months

  6. Reoperation

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

    Measured: 24 months

  7. number of days in the hospital

    number of days in the hospital

    Measured: up to 24 months

  8. Adverse events

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

    Measured: 24 months

  9. 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.

    Measured: 24 months

  10. 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.

    Measured: 24 months

  11. Neurological assessment: Hoffman's and Spurlings

    Testing for positive or negative indication

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start31 Mar 2021
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
58 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05696470
Sponsor's protocol ID
2020H0309
Status last verified
Jun 2025
First submitted
18 Oct 2022
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Radiculopathy and Myelopathy Cervical, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fusion rate (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05696470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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