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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
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The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.
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 Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery.
The Fixed D3 study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with one (1) of the Spinevision posterior fixations systems (Lumis, Plus or Ulis) - retrospective subjects - or subjects planned for treatment with one of the Spinevision posterior fixation system (prospective subjects) can be enrolled in the study.
Standard of care data up to twenty four (24) months post Spinevision posterior fixation system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS) pain, Oswestry Disability Index (ODI) score, and adverse events.
Data will be collected at pre-operative, per-operative, and post-operative Month 2, Month 6, Month 12 and Month 24.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedicle fixation surgery | Device | Pedicle fixation surgery indicates a surgical approach in the thoracic spine down to sacral spine to either support interbody fusion (fusion of the discal space between two vertebrae) , or to correct spinal deformity. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious and non-serious device- and/or procedure-related adverse events | Rate of the serious and non-serious device- and/or procedure-related adverse events will be analyzed and compared to the state of the art. | Month 24 |
| Change of the Oswestry Disability Index (ODI) | Oswestry Disability Index (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 if the art. | Month 2, month 6, month 12 and month 24 |
| Change of the Oswestry Disability Index (ODI) | Mean Oswestry Disability Index (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 one (1) of the SpineVision posterior fixation system (Lumis®, Plus® or Ulis®) 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 |
|---|---|---|
| Benjamin Pommier | Orthéo Neurochirurgie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DOSCEA Pôle Rachis | Recruiting | Bayonne | 64100 | France |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Month 2, month 6, month 12 and month 24 |
| Change of the back and leg Visual Analogue Score (VAS) | Back and leg Visual Analogue Score (VAS) pain 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 du dos Bordeaux-Terrefort | Recruiting | Bruges | 33520 | France |
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| Orthéo Neurochirurgie | Recruiting | Saint-Etienne | 42199 | France |
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