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Improved Implant for Reconstruction Purposes After Mandibular Resection

NCT05153733 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-07-24

No results posted yet for this study

Summary

Study design: A single center non-randomized, prospective clinical feasibility study.

Study population: Study population is composed of 10 patients ineligible for a free-flap bone reconstruction.

Intervention: The selected patients will receive the newly developed, patient-specific RIfRaM mandibular implant.

Objective: The aim is to provide enough evidence through model analysis, physical tests and clinical study of 10 patients that our new type of personalized mandibular implant is safe to use, resulting in significantly fewer complications and can be practically placed during the surgery, without any complications.

Main study parameters/endpoints: The study endpoint is to use the RifRaM without any implant related complications and a perfect mandibular fit.

Conditions

Interventions

DEVICE

RIFRAM implant

Participants will receive the newly developed, patient-specific RIfRaM mandibular implant.

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Baris Karakullukcu, PhD · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2024-03-13
Completion
2024-03-13

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153733 on ClinicalTrials.gov