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

NCT07556978 | Not Yet Recruiting

• 1 other identifier: SN2COOS25072002
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 2

Brief 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. 1.Does the ITC CERVICAL device improve neck disability and pain after surgery?
2. 2.Does the device demonstrate adequate radiological performance in terms of cervical alignment, implant stability, and fusion-related outcomes?
3. 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.

Conditions

Cervical Disc Degenerative Disorder; Cervical Fusion

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index (NDI)

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

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• MT Ortho s.r.l.: lead

Study Sites (2)

"Humanitas" Istituto Clinico Catanese S.p.a.

Misterbianco, Catania, 95045, Italy

Location

Istituto Ortopedico "Villa Salus" Innocenzo

Melilli, Siracusa, 96010, Italy

Location

MeSH Terms

Conditions

Klippel-Feil Syndrome

Condition Hierarchy (Ancestors)

Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Alberto Romano

CONTACT

+39 3687503977; alberto.romano@humanitascatania.it

Dorotea Pugliese

CONTACT

+39 3471701575; dorotea.pugliese@humanitascatania.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

IT (2)