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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 TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down).
Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.
The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium TLIF system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF (prospective subjects) can be enrolled in the study.
Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS), Oswestry Disability Index (ODI) 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 |
|---|---|---|---|---|
| Transforaminal lumbar interbody fusion | Device | Transforaminal Lumbar Interbody Fusion indicates a surgical approach in the lumbar 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. Screws and rods are also added to maintain the level secure while the bones fuse together. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse device and/or procedure related events | Rate of the 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 Oswestry Disability Index (ODI) | ODI mean score at Month 12 will be compared to the ODI mean score at baseline. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion success | Fusion rate will be analyzed and compared to the state of the art. | Month 2, month 6, month 12 and month 24 |
| Change of the Oswestry Disability Index (ODI) | Mean ODI score evolution score will be analyzed. |
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Inclusion Criteria:
Exclusion Criteria: contra-indication
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All patients eligible for treatment or already treated with the Hexanium TLIF system device will be offered to participate in the study; this applies to primary care clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renaud Duchenes | Contact | +33 6 86 16 61 91 | r.duchenes@spinevision.com | |
| Hanta Ranaivoson | Contact | h.ranaivoson@spinevision.com |
| Name | Affiliation | Role |
|---|---|---|
| Noel Graziani, Professor | Hopital Privé Clairval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique du dos Terrefort | Recruiting | Bruges | France |
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| 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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| Month 2, month 6, and month 24 |
| Change of the back and leg Visual Analogue Score (VAS) | Back and leg VAS assessment will be analyzed. | 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 |
| Clinique Saint Charles | Recruiting | Lyon | France |
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| Hopital privé Clairval | Recruiting | Marseille | France |
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| CHRU Nancy | Recruiting | Nancy | France |
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| Polyclinique Majorelle | Recruiting | Nancy | France |
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| Clinicque Générale Beaulieu | Not yet recruiting | Geneva | Switzerland |
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