Italian Title:STUDIO CLINICO LONGITUDINALE, PROSPETTICO, PRE-CE PER LA VALUTAZIONE DELLA EFFICACIA E DELLA SICUREZZA DI UN CAGE INTERVERTEBRALE IN TITANIO ASSOCIATO AD UN SOSTITUTO OSSEO SINTETICO DI NATURA BIOCERAMICA NELLA NORMALE PRASSI CLINICA IN PROCEDURE DI FUSIONE INTERVERTEBRALE English Title: LONGITUDINAL, PROSPECTIVE, PRE-CE CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A TITANIUM INTERVERTEBRAL CAGE ASSOCIATED WITH A BIOCERAMIC SYNTHETIC BONE SUBSTITUTE IN NORMAL CLINICAL PRACTICE IN INTERVERTEBRAL FUSION PROCEDURES

Space clinical study aims to evaluate the performance, in terms of efficacy and safety of an intervertebral spacer associated with a bioceramic bone substitute in the context of intervertebral surgery for degenerative diseases.

Specifically, it is intended to evaluate:

• the capacity for bone regeneration/fusion, defined as absence of loosening and presence of continuous trabecular bone bridge in the absence of radiolucency lines, verified by imaging (CT) and evaluated according to the Brantingan scale;
• the safety of the medical device, through the incidence of any adverse events, complications, unexpected reactions, accidents;
• the improvement of clinical outcome in terms of pain and disability, at 9/14 months follow-up compared with preoperative scores, by clinical indices such as ODI and VAS.