Long-term Safety and Performance of CMF Porous Titanium Implants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Craniomaxillofacial (CMF) porous titanium implant.
- Who it may be relevant to
- Registry conditions: Craniofacial Defects. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CMF SafeTi Fit: Long-term Safety and Performance of CMF Porous Titanium Implants
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Last visit success rate of the device after the surgical implantation of Materialise patient-specific CMF Porous Titanium Implants [Time frame: Last visit (up to 8 years post-implantation)]
Secondary outcome measures (10)
- Perioperative complications related and unrelated to CMF Porous Titanium Implants [Time frame: 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]
- General post-operative complications up to standard of care (SOC) follow-up [Time frame: 4 weeks, 3 months, 1 year, 2-3 years, up to 8 years follow-up]
- Re-intervention rate, implant-related or not [Time frame: Up to 8 years follow-up]
- Intraoperative blood loss (mL) [Time frame: At procedure]
- Technical success of the implantation [Time frame: At procedure]
- Accuracy of the device implantation compared to the pre-operative plan [Time frame: 4 weeks follow-up]
- Implant migration [Time frame: 3 months, 1 year follow-up]
- Implant time of the device [Time frame: From surgery up to 8 years]
- Surgical operation time [Time frame: At procedure]
- Total hospital post-operative stay [Time frame: 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
France · 1 center
- Hôpital Pitié-Salpêtrière — Paris
Identifiers
NCT: NCT06910033 · SMAT011