Long-term Safety and Performance of CMF Porous Titanium Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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

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Craniofacial Defects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No