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

NCT06506695 | Not Yet Recruiting DMC

• 1 other identifier: ONZ-2024-0171
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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. 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. 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

Keywords

Facial defect; Facial Prosthesis; Ear prosthesis; Nose prosthesis; Craniofacial implant; Anaplastology; Prosthesis fabrication

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Difference in surface matching of the midface and temporal area in mm

  6 months after implant placement

• Implant stability over time with implant stability quotient (ISQ) range 1-100

  6 months after implant placement

• Feasibility of remote prosthesis fabrication

  6 months after implant placement

Study Arms (1)

Early loading of craniofacial prosthesis

EXPERIMENTAL

Device: Craniofacial implant placement

Interventions

Craniofacial implant placement 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

Early loading of craniofacial prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: July 17, 2024
• Study Start: September 15, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After study publication for a time period of 5 years
• Access Criteria: Data can be requested via mail to the PI: matthias.ureel@uzgent.be