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RECRUITING
NCT05997121

Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease

Sponsor: SPINEVISION SAS

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

187

Start Date

2021-07-09

Completion Date

2027-10-30

Last Updated

2026-03-18

Healthy Volunteers

Not specified

Interventions

DEVICE

Transforaminal lumbar interbody fusion

Transforaminal Lumbar Interbody Fusion indicates a surgical approach in the lumbar spine to fuse the discal space between two vertebrae. These are joined by removing the disc and placing a cage in its place to restore the vertebral height. Screws and rods are also added to maintain the level secure while the bones fuse together.

Locations (6)

Clinique du dos Terrefort

Bruges, France

Clinique Saint Charles

Lyon, France

Hopital privé Clairval

Marseille, France

CHRU Nancy

Nancy, France

Polyclinique Majorelle

Nancy, France

Clinicque Générale Beaulieu

Geneva, Switzerland