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Recruiting NCT05277818

Post-marketing Clinical Follow-up of the Medical Device DIVA®

◆ AI Clinical Summary
Plain-language summary for patients

Trial Parameters

Condition Lumbar Disc Herniation
Sponsor SC Medica
Study Type OBSERVATIONAL
Phase N/A
Enrollment 822
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-09-07
Completion 2027-03-15
Interventions
Surgery lumbar disc herniation

Eligibility Fast-Check

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Brief Summary

Observational, ambispective, longitudinal, comparative, open, multicentric study. The main objective is to compare the performance of care in patients operated with and without DIVA®.

Eligibility Criteria

Inclusion Criteria: * Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant; * Patient operated for at least 12 months; * Patient able to understand the information related to the study; * Patient having indicated his/her non-opposition to the collection of his/her personal data. Exclusion Criteria: * History of pathologies, malformations or surgical interventions on the spine; * Patient belonging to the first 30 operated by the surgeon with the DIVA® implant; * Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision); * Patient not benefiting from a social security scheme.

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