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

Bioceramed23 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bone Defect Orthopedic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Lusíadas Lisboa

Lisbon, Portugal

Outcomes

Primary Outcomes

Performance Endpoint

the success of bone consolidation on the surgery site, measured by X-ray. This includes radiological assessments (X-rays) to prove bone regeneration and assess the time required for bone consolidation.

Time frame: Follow-up visits according to clinical practice and medical records: months post-surgery until a maximum of 24 months

Safety Endpoint

Assessment of AEs related to TriOSS® during the follow-up period of patients. Description of the event type, duration, determination of Serious Adverse Event (SAE) status, and follow-up of the adverse event.

Time frame: Follow-up visits according to clinical practice and medical records, months post-surgery, until a maximum of 24 months

Data from ClinicalTrials.gov

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