NCT06506695

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2024-09-15
• Primary completion: 2025-09-01
• Completion: 2025-12-31
• First posted: 2024-07-17
• Last updated: 2024-07-17