Evaluation of the Safety and Performance of the TriOSS®: A Retrospective Observational Study in Orthopaedic Area (TriOSSOrto01)

Bioceramed

Status: Terminated

Conditions: Orthopedic; Bone Defect

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07087509

TriOSSOrto01

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.