Clinical Trials Directory

Trials / Completed

CompletedNCT06167122

Treatment Protocol and Long-Term Outcomes in Craniofacial Fibrous Dysplasia

Long-term Follow-up and Treatment Protocol for Craniofacial Fibrous Dysplasia From 40-year Data at Chang Gung Memorial Hospital: A Retrospective Case Series

Status
Completed
Phase
Study type
Observational
Enrollment
13 (actual)
Sponsor
Chang Gung Memorial Hospital · Academic / Other
Sex
All
Age
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECraniofacial reconstructionZone 1 lesions: radical excision and immediate reconstruction with bone grafts for fibrous dysplasia lesions. Zone 2 lesions: trimming \& recontouring. Zone 3 lesions: observation or conservative recontouring; optic nerve decompression performed when continuous deterioration of vision, and external auditory canal surgery performed when cholesteatoma/near total ear canal stenosis. Zone 4: observation or conservative recontouring; orthognathic surgery performed when malocclusion or midface retrusion noted.

Timeline

Start date
2020-03-01
Primary completion
2021-02-10
Completion
2021-03-14
First posted
2023-12-12
Last updated
2023-12-12

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT06167122. Inclusion in this directory is not an endorsement.