An observational study in Lumbar Disc Herniation, sponsored by SC Medica. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-31.
Sponsored by SC Medica · Observational
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.
478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.
This study's planned enrollment of 822 is above the median of 100 across 121 observational studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →SC Medica is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Procedure: Surgery lumbar disc herniation
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
Procedure: Surgery lumbar disc herniation
Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation
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.
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
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Intervertebral Disc Displacement→
SC Medica