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ClinicalTrials.gov ID

NCT06910033

Lead Sponsor

MaterialiseINDUSTRY

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

200Estimated

Last Update Posted

Sep 29, 2025Actual

Start Date

Nov 2025Estimated

Primary Completion Date

Nov 2026Estimated

Completion Date

Nov 2026Estimated

Official Title

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

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 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.

• Craniofacial Defects

• Craniomaxillofacial (CMF) porous titanium implant

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.

Observational Model

Cohort

Time Perspective

Retrospective

Lead Sponsor

MaterialiseINDUSTRY

odile.pomet@aphp.fr+33 (0)1 42 17 82 91