Long-term Safety and Performance of CMF Porous Titanium Implants

NCT06910033 | Not Yet Recruiting

• 1 other identifier: SMAT011
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Craniofacial Defects

Keywords

Craniofacial Defects; Implants

Outcome Measures

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.

  Last visit (up to 8 years post-implantation)

Secondary Outcomes (10)

• Perioperative complications related and unrelated to CMF Porous Titanium Implants

  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

  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)

  At procedure

• Technical success of the implantation

  At procedure

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Materialise: lead

Study Sites (2)

Rigshospitalet

Copenhagen, Denmark

Location

Hôpital Pitié-Salpêtrière

Paris, France

Location

Central Study Contacts

Dorien Haesen, PhD

CONTACT

+32 11 28 69 48; dorien.haesen@archerresearch.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: April 4, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); FR (1)