Health TrialsbyHealthPanel

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

ConditionIntervertebral Disc Degeneration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSPINEVISION SAS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Infection, local to the operative site

Signed of local inflammation

Fever or leukocytosis

Morbid obesity

Trial population

All patients eligible for treatment or already treated with the Hexanium TLIF system device will be offered to participate in the study; this applies to primary care clinic.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Transforaminal lumbar interbody fusion

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Incidence of serious adverse device and/or procedure related events

Rate of the serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.

Time frame
Month 24
2

Change of the Oswestry Disability Index (ODI)

ODI mean score at Month 12 will be compared to the ODI mean score at baseline.

Time frame
Month 12

Secondary outcomes

1

Fusion success

Fusion rate will be analyzed and compared to the state of the art.

Time frame
Month 2, month 6, month 12 and month 24
2

Change of the Oswestry Disability Index (ODI)

Mean ODI score evolution score will be analyzed.

Time frame
Month 2, month 6, and month 24
3

Change of the back and leg Visual Analogue Score (VAS)

Back and leg VAS assessment will be analyzed.

Time frame
Month 2, month 6, month 12 and month 24
4

Incidence of revision surgery at implant site

Rate of revision surgery at implant site will be analyzed and compared to the state of the art.

Time frame
Month 2, month 6, month 12 and month 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SPINEVISION SAS

Lead sponsor

EVAMED

Collaborator

Source ClinicalTrials.gov
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