Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
NCT ID: NCT05997121
Last Updated: 2023-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
187 participants
OBSERVATIONAL
2021-07-09
2027-10-30
Brief Summary
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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.
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Detailed Description
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Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS), Oswestry Disability Index (ODI) score, and adverse events.
Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.
Conditions
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Study Design
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COHORT
OTHER
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Signed of local inflammation
* Fever or leukocytosis
* Morbid obesity
* Pregnancy
* Paediatric cases, or patient still having general skeletal growth
* Spondylolisthesis unable to be reduced to Grade I
* Suspected or documented allergy or intolerance to metal
* Any case where the implant components selected for use would be too large or too small to achieve a successful result
* Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
* Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
* Prior fusion at the level to be treated
* Any case not needing a bone graft or fusion
* Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis
* Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count
* Mental illness
* Any patient unwilling to cooperate with post-operative instructions
18 Years
ALL
No
Sponsors
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EVAMED
OTHER
SPINEVISION SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Noel Graziani, Professor
Role: PRINCIPAL_INVESTIGATOR
Hopital Privé Clairval
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SV005
Identifier Type: -
Identifier Source: org_study_id
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