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

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: Not yet recruiting
• Conditions: Craniofacial Defects
• Intervention / Treatment: Device: Craniomaxillofacial (CMF) porous titanium implant

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: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Dorien Haesen, PhD; Phone Number: +32 11 28 69 48; Email: dorien.haesen@archerresearch.eu

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
    • Contact: Dr. Thomas Kofod; Phone Number: +45 35 45 20 02; Email: tand-mund.rigshospitalet@regionh.dk
• France
  • Paris, France
    • Hôpital Pitié-Salpêtrière
    • Contact: Prof. Thomas Schouman; Phone Number: +33 (0)1 42 17 82 91; Email: odile.pomet@aphp.fr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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	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

Outcome Measure	Measure Description	Time Frame
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.	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.	4 weeks, 3 months, 1 year, 2-3 years, up to 8 years follow-up
Re-intervention rate, implant-related or not		Up to 8 years follow-up
Intraoperative blood loss (mL)	Estimated blood loss by visual inspection or gravimetric method	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.	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.	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.	3 months, 1 year follow-up
Implant time of the device		From surgery up to 8 years
Surgical operation time		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.	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

• Sponsor: Materialise

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Implants; Craniofacial Defects
• Other Study ID 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