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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1
Rigshospitalet
Copenhagen, Denmark
2
Hôpital Pitié-Salpêtrière
Paris, France