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CompletedNCT07556978Updated Jul 28, 2026

Post-market Observational Clinical Study With the CE-marked Implantable Class IIb Medical Device "ITC CERVICAL"

An observational study in Cervical Disc Degenerative Disorder and Cervical Fusion, sponsored by MT Ortho s.r.l.. Completed at 2 sites in Italy. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by MT Ortho s.r.l. · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
32
Ages
18 Years to 84 Years
Sex
All
01

Study summary

The goal of this observational post-market study is to evaluate the clinical performance and safety of the ITC CERVICAL device, a CE-marked implantable cervical interbody fusion cage, in adult patients undergoing anterior cervical discectomy and fusion (ACDF) for symptomatic cervical degenerative disc disease.

The main questions it aims to answer are:

  1. Does the ITC CERVICAL device improve neck disability and pain after surgery?
  2. Does the device demonstrate adequate radiological performance in terms of cervical alignment, implant stability, and fusion-related outcomes?
  3. Is the device safe when used according to its intended purpose? Researchers will review retrospective clinical and radiological data from patients previously treated with the ITC CERVICAL device between 2020 and 2024. The outcomes assessed will include neck disability, pain intensity, neurological function, general health status, cervical lordosis, implant subsidence or migration, need for revision surgery, and the occurrence of adverse events.

Participants included in the study are adult patients who previously underwent two- or three-level ACDF surgery with implantation of the ITC CERVICAL device as part of routine clinical care. Clinical data collected before surgery, within 5 days after surgery, and at 3 months follow-up will be analyzed to assess the device's clinical benefits and safety profile.

02

Conditions studied

  • Cervical Disc Degenerative Disorder
  • Cervical Fusion
03

In context

Lead sponsor

MT Ortho s.r.l. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The subjects involved are patients with cervical disc disease or symptomatic degenerative disc disease, stenosis, radiculopathy and/or spondylosis, treated with cervical cages, aged >18 years

Inclusion criteria

  • The participant must be able to understand the nature, objectives, risks, and benefits of the study and provide free and informed consent, in accordance with current regulations.
  • Patients undergoing primary ACDF (Anterior Cervical Discectomy and Fusion) at two or three (contiguous) levels between C2 and C7
  • Diagnosis of symptomatic degenerative disc disease, including: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, spondylosis, osteophyte complexes, and foraminal stenosis
  • Availability and reliability of the neurological examination and pre- and post-operative clinical and radiological data and medical history
  • Adults (>18 years) treated between 2020 and 2024

Exclusion criteria

Exclusion Criteria:

  • Patients undergoing primary ACDF on a single level between C2 and C7
  • History of previous surgeries in the anatomical area of interest
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
32 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Neck Disability Index (NDI)

    The Neck Disability Index (NDI) is a patient-reported outcome measure assessing neck-related disability. The questionnaire consists of 10 items, each scored from 0 to 5, for a total score ranging from 0 to 50. Higher scores indicate greater disability and therefore a worse outcome. The study will evaluate the change in NDI score between baseline (time of surgery/enrollment) and 3 months after surgery.

    Time frame: From enrollment (which corresponds with the performance of the surgery) within 3 months of the surgery

07

Study locations

2 sites
  • "Humanitas" Istituto Clinico Catanese S.p.a.
    Misterbianco, Catania 95045, Italy
  • Istituto Ortopedico "Villa Salus" Innocenzo
    Melilli, Siracusa 96010, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07556978
Lead sponsor
MT Ortho s.r.l.
Responsible party
Sponsor
First posted
Apr 29, 2026
Start date
May 1, 2026
Primary completion
Jul 24, 2026
Completion
Jul 24, 2026
Last update
Jul 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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