Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down). Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021)

• Patient of 18 years old or more

• Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation

Locations
Other Locations
France
Clinique du dos Terrefort
RECRUITING
Bruges
Clinique Saint Charles
RECRUITING
Lyon
Hopital privé Clairval
RECRUITING
Marseille
CHRU Nancy
RECRUITING
Nancy
Polyclinique Majorelle
RECRUITING
Nancy
Switzerland
Clinicque Générale Beaulieu
NOT_YET_RECRUITING
Geneva
Contact Information
Primary
Renaud Duchenes
r.duchenes@spinevision.com
+33 6 86 16 61 91
Backup
Hanta Ranaivoson
h.ranaivoson@spinevision.com
Time Frame
Start Date: 2021-07-09
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 187
Related Therapeutic Areas
Sponsors
Leads: SPINEVISION SAS
Collaborators: EVAMED

This content was sourced from clinicaltrials.gov

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