NCT06910033

Long-term Safety and Performance of CMF Porous Titanium Implants

CMF SafeTi Fit: Long-term Safety and Performance of CMF Porous Titanium Implants

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Materialise · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this retrospective study is to evaluate the clinical characteristics, efficiency, safety, and long-term performance of craniomaxillofacial (CMF) Porous Titanium Implants within the standard of care across children (0 - \<12 years old), adolescent (12 - \<22 years old), and adult (≥ 22 years old) populations.

Detailed description

The loss of bone substance or continuity in the cranial and/or facial region can result from trauma, infection, benign or malign tumor resection, and therapeutic side effects (e.g., radiotherapy). CMF Porous Titanium Implants are patient-specific solutions matched with the patient's anatomy to reconstruct bone defects accurately. Following a premarket clinical evaluation and considering long-term risk management, the decision to conduct a retrospective post-market clinical follow-up study was based on identifying possible residual risks and uncertainty about long-term safety and clinical performance that may impact the benefit/risk ratio of the CMF porous titanium devices, thereby ensuring the continued safety and efficacy of these CMF devices.

Conditions

• Craniofacial Defects

Interventions

Type	Name	Description
DEVICE	Craniomaxillofacial (CMF) porous titanium implant	All patients were treated, between 2016 and 2023, with patient-specific CMF Porous Titanium Implants for facial and/or cranial reconstruction or restoration of bone defects.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-04-04
• Last updated: 2025-09-29

Locations

2 sites across 2 countries: Denmark, France