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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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index (NDI) | From enrollment (which corresponds with the performance of the surgery) within 3 months of the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alberto Romano | Contact | +39 3687503977 | alberto.romano@humanitascatania.it | |
| Dorotea Pugliese | Contact | +39 3471701575 | dorotea.pugliese@humanitascatania.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Humanitas" Istituto Clinico Catanese S.p.a. | Misterbianco | Catania | 95045 | Italy |
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| ID | Term |
|---|---|
| D007714 | Klippel-Feil Syndrome |
| ID | Term |
|---|---|
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Istituto Ortopedico "Villa Salus" Innocenzo | Melilli | Siracusa | 96010 | Italy |
|
| D009139 |
| Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |