Clinical trial NCT05997121: Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intervertebral Disc Degeneration
Keywords: Lumbar
Spine
Arthrodesis
Fusion
Stabilization
Oswestry disability index
Visual Analogue Score
Lead sponsor: SPINEVISION SAS
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2023-08-18
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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.

Detailed description: The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium TLIF system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF (prospective subjects) can be enrolled in the study.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria: contra-indication

* Infection, local to the operative site
* 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

Primary outcomes:
measure: Incidence of serious adverse device and/or procedure related events
timeFrame: Month 24
measure: Change of the Oswestry Disability Index (ODI)
timeFrame: Month 12
Secondary outcomes:
measure: Fusion success
timeFrame: Month 2, month 6, month 12 and month 24
measure: Change of the Oswestry Disability Index (ODI)
timeFrame: Month 2, month 6, and month 24
measure: Change of the back and leg Visual Analogue Score (VAS)
timeFrame: Month 2, month 6, month 12 and month 24
measure: Incidence of revision surgery at implant site
timeFrame: Month 2, month 6, month 12 and month 24
Other outcomes:
Locations:
city: Bruges
country: France
facility: Clinique du dos Terrefort
city: Lyon
country: France
facility: Clinique Saint Charles
city: Marseille
country: France
facility: Hopital privé Clairval
city: Nancy
country: France
facility: CHRU Nancy
city: Nancy
country: France
facility: Polyclinique Majorelle
city: Geneva
country: Switzerland
facility: Clinicque Générale Beaulieu
Study officials:
affiliation: Hopital Privé Clairval
name: Noel Graziani, Professor
role: PRINCIPAL_INVESTIGATOR
References: