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

Materialise

Status: Not yet enrolling

Conditions: Craniofacial Defects

Treatments: Device: Craniomaxillofacial (CMF) porous titanium implant

Study type: Observational

Funder types: Industry

Identifiers

NCT06910033

SMAT011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.