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| Name | Class |
|---|---|
| EVAMED | OTHER |
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The goal of this observational study is to confirm the safety and efficacy of the Hexanium ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk breaks down) at the cervical spine level (C3-C7).
Part of their standard of care, participants will be questioned on their neck and arm pains, their disability and if they have encountered any adverse effects since the Hexanium ACIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium ACIF system implant surgery.
The Hexanium ACIF study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium ACIF system (retrospective subjects) or subjects planned for treatment with the Hexanium ACIF system (prospective subjects) can be enrolled in hte study.
Standard of care subjects data up to twenty four (24) months post Hexanium ACIF system implant procedure will be collected; key data include neck and arm Visual Analogue Score (VAS), Neck Disability Index (NDI) score, and adverse events.
Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior cervical interbody fusion | Device | Anterior cervical interbody fusion indicates a surgical approach in the cervical spine to fuse the discal space between two vertebrae. These are joined by removing the disc and placing a cage in its place to restore the vertebral height. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse device and/or procedure related events | Rate of serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art. | Month 24 |
| Change of the Neck Disability Index (NDI) | Neck Disability Index (NDI) mean score at Month 12 will be compared to Neck Disability Index (NDI) mean score at baseline. Neck Disability Index (NDI) score varies between 0% and 100%, with highest score as worst outcome. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion success | Fusion rate will be analyzed and compared to the sate of the art. | Month 2, month 6, month 12 and month 24 |
| Change of the Neck Disability index (NDI) | Mean Neck Disability Index (NDI) score evolution will be analyzed. Neck Disability Index (NDI) score varies between 0% and 100%, with highest score as worst outcome. |
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Inclusion Criteria:
Exclusion Criteria: contra-indication
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All patients elligible for treatment or already treated with the Hexanium ACIF system device will be offered to participate in the study; this applies to primary care clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Lucas, Doctor | Centre Hospitalier de l'Europe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique du Dos Terrefort | Bordeaux | 33520 | France | |||
| Centre Hospitalier Privé de l'Europe |
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| Month 2, month 6, month 12 and month 24 |
| Change of the neck and arm Visual Analogue Score (VAS) | Neck and arm Visual Analogue Score (VAS) assessments will be analyzed. Visual Analogue Score (VAS) is a pain scoring, with score varying from 0 (no pain) to 10 (worst pain, unbearable, excrutiating pain) | Month 2, month 6, month 12 and month 24 |
| Incidence of revision surgery at implant site | Rate of revision surgery at implant site will be analyzed and compared to the state of the art. | Month 2, month 6, month 12 and month 24 |
| Le Port-Marly |
| 785620 |
| France |
| CHRU de Nancy | Nancy | 54000 | France |
| Polyclinique Majorelle | Nancy | 54000 | France |
| Hôpital Privé du Dos Francheville | Périgueux | 24000 | France |
| Hôpital Robert Schuman - UNEOS | Vantoux | 57070 | France |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
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