Cervical Disc Degenerative Disorder, Cervical Fusion
Conditions
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. 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.
Interventions
None listed
Sponsors
MT Ortho s.r.l.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index (NDI) | 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. |
Countries
Italy
Outcome results
None listed