NCT07556978

Completed

Post-market Observational Clinical Study With the CE-marked ...

MT Ortho s.r.l.Source

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Other study identifiers

Sponsor study identifier

SN2COOS25072002

Study Type

observational

Actual enrollment (reported)

32

Locations

1 country

Sites

2

Timeline

Study Start

May 1, 2026

Actual (reported)

Primary Completion

July 24, 2026

Actual (reported)

Study Completion

July 24, 2026

Actual (reported)

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.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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 32 participants
Study completion date: July 24, 2026
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 22, 2026
Actual (reported)
First Posted
April 29, 2026
Actual (reported)
Study Start
May 1, 2026
Actual (reported)
Primary Completion
July 24, 2026
Actual (reported)
Study Completion
July 24, 2026
Actual (reported)

Last Updated: July 28, 2026
Status Verified: July 2026
Last Update Submitted: July 27, 2026

Conditions

Cervical Disc Degenerative Disorder Cervical Fusion

Outcome Measures

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

Eligibility Criteria

Age18 Years - 84 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

MT Ortho s.r.l.
Industrylead

Study Sites (2)

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

Misterbianco, Catania, 95045, Italy

Istituto Ortopedico "Villa Salus" Innocenzo

Melilli, Siracusa, 96010, Italy

MeSH Terms

Conditions

Klippel-Feil Syndrome

Condition Hierarchy (Ancestors)

DysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Enrollment

32 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT04605120

Allogeinic Bone Paste

Not ApplicableUnknown

NCT06066879

Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery

Phase 4Unknown

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

Contact the study team to confirm eligibility.

Primary Completion

July 24, 2026

Actual (reported)

Study Completion

July 24, 2026

Actual (reported)

Last Updated

July 28, 2026

Record last verified: 2026-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07556978
Data provider: ClinicalTrials.gov
Source updated: 2026-07-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:43 UTC

Locations

IT(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations