Safety and performance of the Hexanium TLIF system in the treatment of skeletally mature patients with degenerative disc disease – HEXANIUM TLIF Study

Criteria for participation in trial
1. Patient implanted with / scheduled for implantation with the Hexanium TLIF device: • Patient already implanted with the Hexanium TLIF (implantation date not earlier than July 2021), or • Patient scheduled for implantation with the Hexanium TLIF implant; 2. Patient aged 18 years or older; 3. Patient who has given signed consent or has not opposed the collection of their data, according to local regulations. (BASEC)

Exclusion criteria
The contraindications are as follows: - a local infection at the surgical site; - signs of local inflammation; - fever or leukocytosis; - morbid obesity; - pregnancy; - pediatric cases or patients whose skeleton is still undergoing general growth; - cases of spondylolisthesis (vertebral slippage) where reduction to grade I is impossible; - a proven or suspected allergy or intolerance to metals; - any case where the selected components for implantation are too large or too small to achieve the desired outcome; - any patient whose tissue coverage of the surgical site is inadequate, or whose bone quality or capital is poor; - any patient for whom the use of an implant would compromise the anatomical structures or expected physiological performance; - a previous arthrodesis at the level to be treated; an arthrodesis is a surgical procedure that involves fusing two or more vertebrae together to treat a back problem; - any case that does not require a bone graft or an arthrodesis; - any presence of an anomaly compromising the normal process of bone remodeling including, but not limited to: severe osteoporosis involving the spine, bone resorption, osteopenia, primary or metastatic tumors involving the spine, active infection at the site or proven metabolic disorders compromising osteogenesis; - mental disorders; - any patient unwilling to comply with post-operative instructions. (BASEC)