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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Fusion; Cervical Disc Degenerative Disorder

• Study Type: Observational
• Enrollment (Estimated): 33

Contacts and Locations

• Study Contact: Name: Alberto Romano; Phone Number: +39 3687503977; Email: alberto.romano@humanitascatania.it
• Study Contact Backup: Name: Dorotea Pugliese; Phone Number: +39 3471701575; Email: dorotea.pugliese@humanitascatania.it

Study Locations

• Italy
  • Catania
    • Misterbianco, Catania, Italy, 95045
      • "Humanitas" Istituto Clinico Catanese S.p.a.
      • Contact: Alberto Romano; Phone Number: +39 3687503977; Email: alberto.romano@humanitascatania.it
  • Siracusa
    • Melilli, Siracusa, Italy, 96010
      • Istituto Ortopedico "Villa Salus" Innocenzo
      • Contact: Alberto Romano; Phone Number: +39 3687503977; Email: alberto.romano@humanitascatania.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

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:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neck Disability Index (NDI)	From enrollment (which corresponds with the performance of the surgery) within 3 months of the surgery

Collaborators and Investigators

• Sponsor: MT Ortho s.r.l.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Dysostoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Klippel-Feil Syndrome
• Other Study ID Numbers: SN2COOS25072002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No