Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506695
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-01
Brief Title:
Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication A Prospective Cohort Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Facial defects created by trauma oncological procedures or congenital conditions can be repaired with ear nose andor 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None