Status:

NOT_YET_RECRUITING

Long-term Safety and Performance of CMF Porous Titanium Implants

Lead Sponsor:

Materialise

Conditions:

Craniofacial Defects

Eligibility:

All Genders

Brief 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 standar...

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...

Eligibility Criteria

Inclusion

  • Age: Patients of any age are eligible for this study.
  • Patients treated with Materialise patient-specific CMF Porous Titanium Implants for facial and/or cranial reconstruction.
  • Patients who have followed Standard of Care, as determined in each case by the treating surgeon.

Exclusion

  • Known hypersensitivity to Titanium at the time of surgery.
  • Patients who had or will receive the TMJ Total Arthroplasty System.
  • Pregnancy at the time of surgery.

Key Trial Info

Start Date :

November 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 1 2026

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06910033

Start Date

November 1 2025

End Date

November 1 2026

Last Update

September 29 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Rigshospitalet

Copenhagen, Denmark

2

Hôpital Pitié-Salpêtrière

Paris, France