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Observational, ambispective, longitudinal, comparative, open, multicentric study.
The main objective is to compare the performance of care in patients operated with and without DIVA®.
The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with medical device DIVA® | Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with DIVA® implant |
| |
| Patient without medical device DIVA® | Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated without DIVA® implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery lumbar disc herniation | Procedure | Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively. | The main analysis will compare the rates of patients requiring reoperation due to any cause (excluding trauma) on the lumbar spine 5 years after surgery between the group with DIVA® and the group without DIVA®, using a Chi-square test. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with the DIVA® device operated in the study centers for at least 12 months (with the exception of the first 30 operated by practitioner, to take into account the learning curve), as well as all patients operated on over a period similar before the installation of DIVA® in the establishment, will receive the information note of the study. if the patient agrees to participate to the study, patient's data will be collected on a case report form.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurélie MULLER | Contact | +33 3 88 23 71 04 | dpo@sc-medica.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Civils de Colmar | Recruiting | Colmar | France |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |