Evaluation of the Safety and Performance of the TriOSS®: A Retrospective Observational Study in Orthopaedic Area

Evaluation of the Safety and Performance of the TriOSS®: A Retrospective Observational Study in Orthopaedic Area

This study aims to collect real-world clinical data to gather information on the performance and safety of the TriOSS® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation.

Inclusion Criteria:

• Adult males or females (age > 18 years old);
• Patients with osseous defects, either of trauma origin, surgically created, or associated with spinal degenerative diseases that require segmental fusion of the spine.
• Patients with bone skeletal defects that are not intrinsic to the stability of the bone structure.

Exclusion Criteria:

• Signs of local or systemic acute/ active or chronic infections;
• Metabolic affections;
• Severe degenerative diseases, conditions in which general bone grafting is not advisable;
• Implementation sites that allow product migration;
• Conditions which require structural support in the skeletal system;
• Conditions where the implantation site is unstable and not rigidly fixated;
• Sensibility to the implantable materials;
• Known hypersensitivity to the implant material.