Cervical Disc Degenerative DisorderNCT07556978
Post-market Observational Clinical Study With the CE-marked Implantable Class IIb Medical Device "ITC CERVICAL"
An observational study of Cervical Disc Degenerative Disorder and Cervical Fusion, run by MT Ortho s.r.l. at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Cervical Disc Degenerative Disorder, Cervical Fusion
- How many people
- 32 participants
- Where
- 2 sitesItaly
- Study dates
- 1 May 2026to 24 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients undergoing primary ACDF on a single level between C2 and C7
- History of previous surgeries in the anatomical area of interest
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Istituto Ortopedico "Villa Salus" Innocenzo
Melilli, Siracusa, 96010
"Humanitas" Istituto Clinico Catanese S.p.a.
Misterbianco, Catania, 95045
About this study
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:
Read more
- Does the ITC CERVICAL device improve neck disability and pain after surgery?
- Does the device demonstrate adequate radiological performance in terms of cervical alignment, implant stability, and fusion-related outcomes?
- 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.
- Medical subject headings
- Klippel-Feil Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment (which corresponds with the performance of the surgery) within 3 months of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 May 2026
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc Degenerative DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- MT Ortho s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556978
- Sponsor's protocol ID
- SN2COOS25072002
- Status last verified
- Jul 2026
- First submitted
- 22 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Observational Clinical Study With the CE-marked Implantable Class IIb Medical Device "ITC CERVICAL"
- ClinicalTrials.gov ID
- NCT07556978
- Acronym / sponsor ID
- SN2COOS25072002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- MT Ortho s.r.l.Industry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the ITC CERVICAL device improve neck disability and pain after surgery?
- Does the device demonstrate adequate radiological performance in terms of cervical alignment, implant stability, and fusion-related outcomes?
- 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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients undergoing primary ACDF on a single level between C2 and C7
- History of previous surgeries in the anatomical area of interest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neck Disability Index (NDI)
Time frame: From enrollment (which corresponds with the performance of the surgery) within 3 months of the surgery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Degenerative Disorder and Cervical Fusion, run by MT Ortho s.r.l. at 2 sites in Italy.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neck Disability Index (NDI) (time frame: From enrollment (which corresponds with the performance of the surgery) within 3 months of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.