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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07087509

Acronym

TriOSSOrto01

Enrollment

Registered

2025-07-28

Start date

2025-09-30

Completion date

2026-01-05

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Defect, Orthopedic

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Performance Endpoint	Follow-up visits according to clinical practice and medical records: months post-surgery until a maximum of 24 months	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.
Safety Endpoint	Follow-up visits according to clinical practice and medical records, months post-surgery, until a maximum of 24 months	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.

Countries

Portugal

Outcome results