Clinical trial NCT06910033: Long-term Safety and Performance of CMF Porous Titanium Implants
Official title: CMF SafeTi Fit: Long-term Safety and Performance of CMF Porous Titanium Implants
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Craniofacial Defects
Keywords: Craniofacial Defects
Implants
Lead sponsor: Materialise
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective collection of a minimum of 200 patients that were treated between 2016 and 2023 with patient-specific CMF Porous Titanium Implants for facial and/or cranial reconstruction or restoration of bone defects. All patients included in the study underwent standard visits and follow-up assessments in-hospital.

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.

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.

Primary outcomes:
measure: Last visit success rate of the device after the surgical implantation of Materialise patient-specific CMF Porous Titanium Implants
timeFrame: Last visit (up to 8 years post-implantation)
Secondary outcomes:
measure: Perioperative complications related and unrelated to CMF Porous Titanium Implants
timeFrame: Up to the moment the patient is discharged from the hospital after the procedure (discharge), up to several weeks, depending on defect severity and recovery progress
measure: General post-operative complications up to standard of care (SOC) follow-up
timeFrame: 4 weeks, 3 months, 1 year, 2-3 years, up to 8 years follow-up
measure: Re-intervention rate, implant-related or not
timeFrame: Up to 8 years follow-up
measure: Intraoperative blood loss (mL)
timeFrame: At procedure
measure: Technical success of the implantation
timeFrame: At procedure
measure: Accuracy of the device implantation compared to the pre-operative plan
timeFrame: 4 weeks follow-up
measure: Implant migration
timeFrame: 3 months, 1 year follow-up
measure: Implant time of the device
timeFrame: From surgery up to 8 years
measure: Surgical operation time
timeFrame: At procedure
measure: Total hospital post-operative stay
timeFrame: Up to the moment the patient is discharged from the hospital after the procedure (discharge), up to several weeks, depending on defect severity and recovery progress
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
Study officials:
References: