Safety and performance of SPINEVISION's Hexanium®

Low back pain (LBP) is a major health problem in so-called Western countries, sometimes referred to as the disease of the century, and is responsible for considerable economic, socio-professional and, of course, quality of life repercussions for patients. A variety of conditions can cause low back pain, one of which is degenerative disc disease, which results from the natural breakdown of an intervertebral disc in the spinal column. This degeneration is often the result of natural daily stresses and minor injuries associated with the individual intrinsic quality of the intervertebral cartilage. Degenerative disc disease in its simplest form is generally treated with exercises, medication (painkillers), physiotherapy or infiltrations, known as conservative treatment. When these standard treatments prove ineffective, lumbar fusion surgery is considered.

One of the lumbar fusion surgical techniques is called «transforaminal lumbar intervertebral fusion or TLIF»; this minimally invasive technique is already well established/recognised and consists of permanently relieving stress on the neurological structures while permanently reconstructing the vertebral architecture (lordosis, disc height, size of the spinal canal and foramen). It consists of implanting a medical device (called a cage or spacer) in place of the defective intervertebral disc, which will have been removed beforehand (partially or entirely). This cage will then be colonised by the patient's bone to achieve biological fusion between the vertebrae concerned within 6 to 12 months. There is already research on degenerative disc disease in humans. Studies carried out to date have demonstrated the performance and safety of the surgery referred to above. In addition to the technique, developments also concern biomaterials and have seen the PEEK spacers formerly used gradually replaced by Titanium spacers and more particularly and recently by 3D Titanium Printing technology.

The data collected will include the following parameters: medical history, demographics, type of profession, surgical data (blood loss, duration, complications), pre-, per- and post-operative radiological assessments, quality of fusion, tolerance of the device, clinical and functional evaluation questionnaires, pain scale, patient satisfaction, repeat surgery (if applicable), side effects (if applicable), drugs.

As well as publishing the results in an international scientific journal and presenting scientific papers at international congresses, the current objectives include developing a reference centre in Geneva with educational activities and live demonstrations, including visits from foreign surgeons, and training the clinic's paramedical staff.

The principal investigator for Switzerland is Dr. F. Schils, Neurosurgeon (Clinique Générale-Beaulieu, Geneva); the co-investigators are Dr. N. Graziani (Marseille), Dr. E. Favreul (Lyon), Dr. Mansouri (Nancy), Dr. A. Toquart (Nancy), Dr. I. Obeid (Bordeaux), and Dr R. Gondar (Geneva).