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

September 26, 2025 updated by: Materialise

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Last visit (up to 8 years post-implantation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
Up to 8 years follow-up
Intraoperative blood loss (mL)
Time Frame: At procedure
Estimated blood loss by visual inspection or gravimetric method
At procedure
Technical success of the implantation
Time Frame: At procedure
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.
At procedure
Accuracy of the device implantation compared to the pre-operative plan
Time Frame: 4 weeks follow-up
Accuracy will be quantified by superpositioning the post-operative images with the planning.
4 weeks follow-up
Implant migration
Time Frame: 3 months, 1 year follow-up
Migration will be quantified by calculating the difference between the immediate post-operative and 3-month and 1-year post-operative scans.
3 months, 1 year follow-up
Implant time of the device
Time Frame: From surgery up to 8 years
From surgery up to 8 years
Surgical operation time
Time Frame: At procedure
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Materialise

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMAT011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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