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

NCT07087509 | Terminated

• 1 other identifier: TriOSSOrto01
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Defect; Orthopedic

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (\> 18 years old) undergoing orthopaedic surgery after bone defect.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioceramed: lead
• Hospital dos Lusíadas: collaborator

Study Sites (1)

Hospital Lusíadas Lisboa

Lisbon, Portugal

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 28, 2025
• Study Start: September 30, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)