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

Launched by SPINEVISION SAS · Aug 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new spinal implant system called the Hexanium TLIF system, designed to help patients with degenerative disc disease. This condition occurs when the disks in the spine break down, causing pain and difficulty moving. The trial is open to adults aged 18 and older who are scheduled for surgery to receive this implant or who have already received it after July 2021. However, certain individuals may not be eligible, including those with infections, significant obesity, pregnancy, or certain spinal conditions.

Participants in the trial will be asked about their back and leg pain, any difficulties they might have in daily activities, and any side effects they may experience after the surgery. The information will be collected for up to two years following the surgery, helping researchers understand how well the Hexanium TLIF system works and if it is safe to use. This trial is currently looking for participants, and it’s a great opportunity for those who want to contribute to research that may improve treatment options for spinal health.

Gender

ALL

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