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

NCT05997121 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 187

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • Intervertebral Disc Degeneration

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.

Sponsors & Collaborators

  • EVAMED

    collaborator OTHER

  • SPINEVISION SAS

    lead INDUSTRY

Principal Investigators

  • Noel Graziani, Professor · Hopital Privé Clairval

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2027-10-30
Completion
2027-10-30
FDA Device
Yes

Countries

  • France
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997121 on ClinicalTrials.gov