Use of the Bone Substitute SintLife® in Vertebral Arthrodesis Procedures. A Pilot Study.

Detailed Summary

This pilot study is to evaluate the potential effectiveness of bone substitute SintLife within the spinal surgery in spinal stabilization applications for degenerative diseases. In particular, the investigators propose to evaluate: * the ability of bone regeneration/ fusion, defined as the presence of trabecular bone continuous bridge and absence of radiolucent lines, verified by diagnostic imaging in accordance with the Brantigan scale; * the patient's state of health, evaluated through the comparison of the functional-symptom pattern between the pre- and post-operative phases, verified by Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and EuroQol (EQ-5D); * the safety of the medical device, evaluated through the impact of any adverse events, complications, unexpected reactions, accidents. STUDY DESIGN This collection of clinical data is set up as pilot study post-marketing. In the study will be included all consecutive patients who require spinal fusion surgery, in accordance with the inclusion and exclusion criteria after signing the informed consent. Patients will be treated and followed postoperatively according to the normal clinical, surgical and therapeutic practice, in place at the Rizzoli Orthopaedic Institute of Bologna. The total duration of data collection is 36 months: * the stage of patient enrollment is 18 months from the date of approval of the study by the Ethics Committee of the center; * the phase of post-operative monitoring is 18 months, with planned at 6, 12 and 18 months follow-up (± 15 days before scheduled date).

Study Details

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Interventions