Craniofacial DefectsCMF SafeTi FitNCT06910033
Long-term Safety and Performance of CMF Porous Titanium Implants
An observational study of Craniofacial Defects, run by Materialise at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Craniofacial Defects
- What is being tested?
- Craniomaxillofacial (CMF) porous titanium implant
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Nov 2025to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
Official title: CMF SafeTi Fit: Long-term Safety and Performance of CMF Porous Titanium Implants
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.
Read the 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.
- Conditions
- Craniofacial Defects
- Being tested
- Craniomaxillofacial (CMF) porous titanium implant
- Keywords
- Craniofacial Defects, Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniomaxillofacial (CMF) porous titanium implantDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Last visit success rate of the device after the surgical implantation of Materialise patient-specific CMF Porous Titanium Implants
Success is defined as follows:
- The device is securely in place and functional as of the last follow-up or until its removal for reasons unrelated to the device itself.
Failure is defined as follows:
- Reoperation without device removal related to the device.
- Reoperation with device removal related to the device.
Measured: Last visit (up to 8 years post-implantation)
Secondary outcomes (10)
Perioperative complications related and unrelated to CMF Porous Titanium Implants
Complications related and unrelated to CMF Porous Titanium Implants, including allergic reaction to the anesthetic or titanium (anaphylaxis), complications related to the anesthesia, hematoma, or others.
Measured: 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
Complications related and unrelated to CMF Porous Titanium Implants, including infection, pain, implant migration, implant exposure, failure of implant, device subsidence, device fracture, diplopia, hematoma, dysesthesia, osteolysis, fistula, wound dehiscence, delayed healing, or others.
Measured: 4 weeks, 3 months, 1 year, 2-3 years, up to 8 years follow-up
Re-intervention rate, implant-related or not
Measured: Up to 8 years follow-up
Intraoperative blood loss (mL)
Estimated blood loss by visual inspection or gravimetric method
Measured: At procedure
Technical success of the implantation
Defined by the surgeon, including but not limited to the implantation of the CMF Porous Titanium Implant and guides (if applicable) according to the pre-operative plan without technical difficulties, including design issues, placement issues, planning issues, guides, or others.
Measured: At procedure
Accuracy of the device implantation compared to the pre-operative plan
Accuracy will be quantified by superpositioning the post-operative images with the planning.
Measured: 4 weeks follow-up
Implant migration
Migration will be quantified by calculating the difference between the immediate post-operative and 3-month and 1-year post-operative scans.
Measured: 3 months, 1 year follow-up
Implant time of the device
Measured: From surgery up to 8 years
Surgical operation time
Measured: At procedure
Total hospital post-operative stay
Time of discharge will be registered in eCRF. Post-operative treatment carried out according to the standard practice of the investigational sites will be registered in the eCRF.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start17 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Materialise
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910033
- Sponsor's protocol ID
- SMAT011
- Acronym
- CMF SafeTi Fit
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMF SafeTi Fit: Long-term Safety and Performance of CMF Porous Titanium Implants
- ClinicalTrials.gov ID
- NCT06910033
- Acronym / sponsor ID
- CMF SafeTi Fit / SMAT011
- Conditions
- Craniofacial Defects
- Keywords
- Craniofacial Defects, Implants
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MaterialiseIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Craniomaxillofacial (CMF) porous titanium implantAll 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. | Device | – |
Primary outcome
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)
Success is defined as follows: - The device is securely in place and functional as of the last follow-up or until its removal for reasons unrelated to the device itself. Failure is defined as follows: * Reoperation without device removal related to the device. * Reoperation with device removal related to the device.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniofacial Defects, run by Materialise at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.