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NCT Number: NCT06910033

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.

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Key information

Conditions

Craniofacial Defects

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Craniomaxillofacial (CMF) porous titanium implant

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Re-intervention rate, implant-related or not

    Time frame: Up to 8 years follow-up

  4. Intraoperative blood loss (mL)

    Time frame: At procedure

    Estimated blood loss by visual inspection or gravimetric method

  5. 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.

  6. 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.

  7. 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.

  8. Implant time of the device

    Time frame: From surgery up to 8 years

  9. Surgical operation time

    Time frame: At procedure

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dorien Haesen, PhD

CONTACT

[email protected]

+32 11 28 69 48

Sponsors and collaborators

Lead sponsor

Materialise

Industry

Registry information

Official study title

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

Acronym: CMF SafeTi Fit

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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