Treatment Protocol and Long-Term Outcomes in Craniofacial Fibrous Dysplasia

Completed

• Conditions: Craniofacial Fibrous Dysplasia
• Interventions: Procedure: Craniofacial reconstruction

• Registration Number: NCT06167122
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Craniofacial fibrous dysplasia (CFD) is a nonneoplastic disease characterized by fibro-osseous lesions in the affected bones. Treatment is mainly surgical and is stratified based on four different anatomical zones. This study aimed to evaluate the long-term outcomes and refine the algorithm for CFD.

Detailed Description

According to Chen et. al for the appropriate surgical management of FD the craniofacial skeleton can be divided into four zones according to the consideration of facial cosmesis, vital anatomical region and function preserving. The aim of the study was to evaluate the outcome of nearly 40 years long-term follow up cohort group and refine the algorithm of surgical intervention of FD under 4 zones classification.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-02-10
• Study Completion: 2021-03-14
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Received CFD surgical intervention between 1972 and 2019
• Personal interviews: between late 2019 and 2020, covering a postoperative period of over 20 years
• All the surgery were performed by a senior surgeon (Yu-Ray Chen) at Chang Gung Craniofacial Center

Exclusion Criteria

• Patients who underwent surgical treatment at other institutions during the follow-up period or those who did not return to the craniofacial outpatient department for follow-up and receive computed tomography scans between 2019 and 2020 will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Craniofacial fibrous dysplasia	Craniofacial reconstruction	Fibro-osseous lesions within the affected bones based on image, and surgical intervention based on 4 different anatomical zones.

Primary Outcome Measures

Name	Time	Method
Recurrence	Personal interviews with facial bone computed tomography obtained on late 2019 and 2020	Recurrence based on facial bone computed tomography

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan