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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Implant Complication; Facial Deformity
• Intervention / Treatment: Device: Craniofacial implant placement

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early loading of craniofacial prosthesis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of implant survival in nasal and temporal bone from 0-100%	Investigate craniofacial implant survival. 100% being better than 0%.	6 months after placement of implants
Peri-implant complications using the Holgers' (grade 0-4)	Investigate craniofacial peri-implant complications after early loading concept using the Holgers' scale from 0, meaning excellent peri-implant status to 4 necessitating removal of the implant.	6 months after placement of implants
Peri-implant complications using the IPS scale (IPS-score)	Investigate craniofacial peri-implant complications after early loading concept using the IPS scale. Only the 'percutaneous' part of the scale will be used. IPS scale ranges from no treatment to removal of the implant.	6 months after placement of implants
Quality of Life with SF-36, SWLS and RSES and self-made questionnaire	Assessing the patient's quality of life using the early loading protocol with standardised and self-made questionnaires. The SF-36 scoring will result in 8 scales ranging from 0-100 with the lower the score the more disability. SWLS will result in a range of 5-35. The higher the score the higher the satisfaction with life. RSES ranges from 0-30. Scores between 15 and 25 are considered in the normal range whereas scores below 15 suggest low self-esteem. The self-made questionnaires will result in percentages of the given answers.	Before treatment and 6 months after implant placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in surface matching of the midface and temporal area in mm	By matching and comparing surface scans we can analyse the swelling in the midface and temporal area after directly after surgery and postoperatively. These will result in positive or negative changes and expressed in millimeters.	6 months after implant placement
Implant stability over time with implant stability quotient (ISQ) range 1-100	By measuring stability we can create an osseointegration timeline for craniofacial implants. Higher values indicate higher stability. Values in between 55 and 85 are considered acceptable.	6 months after implant placement
Feasibility of remote prosthesis fabrication	Questionnaires assessing the experience of the patient and aesthetics of the prosthesis	6 months after implant placement

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Facial defect; Facial Prosthesis; Ear prosthesis; Nose prosthesis; Craniofacial implant; Anaplastology; Prosthesis fabrication
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: ONZ-2024-0171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized raw data will be shared with the scientific community. All materials that can be used to identify the patient such as face scans and clinical pictures will not be shared.
• IPD Sharing Time Frame: After study publication for a time period of 5 years
• IPD Sharing Access Criteria: Data can be requested via mail to the PI: matthias.ureel@uzgent.be
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No