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

NCT05277818 | Recruiting

• 1 other identifier: 2021-A02667-34
• Study Type: observational
• Target: 822
• Locations: 1 country
• Sites: 1

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®.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Procedure: Surgery lumbar disc herniation

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

Procedure: Surgery lumbar disc herniation

Interventions

Surgery lumbar disc herniation PROCEDURE

Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation

Patient with medical device DIVA®; Patient without medical device DIVA®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SC Medica: lead

Study Sites (1)

Hôpitaux Civils de Colmar

Colmar, France

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aurélie MULLER

CONTACT

+33 3 88 23 71 04; dpo@sc-medica.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: September 7, 2022
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)