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

Study acronym: TLIF
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv3
  2. Primary endpoints revised (2)
    • Eligibility criteria revised
    • Secondary endpoints revised (4)
    • Study description revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05997121
Lead Sponsor SPINEVISION SAS
Collaborators: EVAMED
Conditions
(from sponsor)		 Intervertebral Disc Degeneration
Related terms Ankylosis, Intervertebral Disc Degeneration
Enrollment 187 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov