Actively Recruiting
Clinical Follow-up of the DIVA e Device in Lumbar Disc Herniation Surgery
Led by SC Medica · Updated on 2022-10-31
822
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the care outcomes for adult patients who have undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation. The study focuses on patients operated with and without the DIVA e medical device. It is an observational, ambispective, longitudinal, comparative, open, multicenter study led by SC Medica to better understand the device's impact in real-world settings. Participants include adults who had lumbar disc herniation surgery at least 12 months ago. They are grouped based on whether their surgery involved the DIVA e implant or not. The main procedure studied is the surgical treatment of the herniation. The study observes these groups over time to compare reoperation rates and other outcomes without assigning treatments. During the study, researchers will track participants' health and any reoperations on the lumbar spine for up to five years after surgery. They will collect personal health data and monitor the rates of reoperation for any reason except trauma. Participants must understand the study details and consent to data use. This long-term follow-up allows evaluation of the device's performance through routine clinical observations and data collection.
CONDITIONS
Brief Title
Post-marketing Clinical Follow-up of the Medical Device DIVA®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 e 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
You will not qualify if you...
- History of pathologies, malformations or surgical interventions on the spine
- Patient belonging to the first 30 operated by the surgeon with the DIVA e implant
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision)
- Patient not benefiting from a social security scheme
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 years postoperatively
Participants who have undergone lumbar disc herniation surgery are observed to assess the rates of reoperation on the lumbar spine over time.
Visits occur periodically over 5 years to monitor health status and potential reoperation
Trial Site Locations
Total: 1 location
1
Hôpitaux Civils de Colmar
Colmar, France
Actively Recruiting
Research Team
A
Aurélie MULLER
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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