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.

Inclusion Criteria:

• Patients who have provided hospital consent for surgical treatment;
• Male patients and non-pregnant female patients between the ages of 18 and 75 years;
• Patients requiring single-level interbody fusion in the L3-L4 and L4-L5 tract;
• Patients with degenerative diseases of the spine, such as lumbar canal stenosis, lumbar discopathy, degenerative spondylolisthesis grade I;
• Patients with a BMI <= 30;
• Patients physically and mentally willing and able to comply with postoperative indications;
• Patient able to understand the Italian language;
• If the investigator decides to fuse an additional level for spinal stability during surgery, this is not an exclusion criterion; however, only one level will be measured to comply with the surgical indication.
• Female patients who are pregnant or planning to become pregnant during the course of the study;
• Obese patients with a BMI index > 30.

Exclusion Criteria:

Patients with:

• systemic or localized infection;
• Inflammatory or autoimmune disease;
• hypercalcemia;
• coagulation disorders;
• metabolic disorders;
• insulin-dependent diabetes;
• alterations or complications of thyroid function;
• overt allergy to calcium phosphate salts;
• self-reported allergies to drugs and/or medical devices;
• tumor and/or infectious diseases of the spine;
• active neoplasms;

In addition, patients who:

• Abuse alcohol and drugs;
• Are affected by smoking (> 20 cigarettes/day);
• Are on drug therapy that causes alteration of bone regeneration (e.g., chemotherapy);
• already had surgery (revision surgery).