Health TrialsbyHealthPanel

Long-term Safety and Performance of CMF Porous Titanium Implants

ConditionCraniofacial Defects
Trial statusEnrolling by invitation
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMaterialise

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Last visit (up to 8 years post-implantation)

Secondary outcomes

1

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.

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
2

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.

Time frame
4 weeks, 3 months, 1 year, 2-3 years, up to 8 years follow-up
3

Re-intervention rate, implant-related or not

Time frame
Up to 8 years follow-up
4

Intraoperative blood loss (mL)

Estimated blood loss by visual inspection or gravimetric method

Time frame
At procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Materialise

Lead sponsor

Source ClinicalTrials.gov
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