Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study

NCT ID: NCT06506695

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-12-31

Brief Summary

Facial defects created by trauma, oncological procedures or congenital conditions can be repaired with ear, nose and/or eye prostheses. These are fixed on intraosseous implants placed in the temporal, nasal and orbital bone. To date, an osseointegration period of 3-6 months is maintained after which the implants are loaded.

This study aims to achieve two goals:

1. To load the implants with a nose or ear prosthesis within one month (preferably <3 weeks). Patients with an orbital prosthesis will not be recruited. In other words, an optimization of an existing protocol will be investigated. The quality of life of the patients as well as possible complications of the implants will be investigated.

2. Because of the short time between the surgery and the placement of the prosthesis, the prosthesis will be fabricated remotely. This means that the patient will not have to travel to the prosthetist. The feasibility and aesthetics will be analyzed through questionnaires for the patient.

Conditions

Facial Deformity; Implant Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early loading of craniofacial prosthesis

Group Type: EXPERIMENTAL

Craniofacial implant placement

Intervention Type: DEVICE

• Resection of oncologic process or remnants after trauma if necessary
• Placement of craniofacial implants in the nasal floor and/or the temporal bone.
• Placement of split thickness skin graft around the implants
• Placement of nose and/or ear prosthesis within 3 weeks

Interventions

Craniofacial implant placement

• Resection of oncologic process or remnants after trauma if necessary
• Placement of craniofacial implants in the nasal floor and/or the temporal bone.
• Placement of split thickness skin graft around the implants
• Placement of nose and/or ear prosthesis within 3 weeks

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients with a facial defect in the nasal and/or temporal area that will not be repaired with autologous tissue;
• Adult patients receiving oncological resection or trauma resulting in a facial defect in the nose and/or ear that will not be repaired with autologous tissue;
• Patients who can come to the hospital every week for 6 weeks.

Exclusion Criteria

• Patients with insufficient bone mass for implant placement
• Patients who cannot come to the hospital for weekly follow-ups
• Patients that wish an autologous reconstruction
• Patient is unable to tolerate general anesthesia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ONZ-2024-0171

Identifier Type: -

Identifier Source: org_study_id