Treatment Protocol and Long-Term Outcomes in Craniofacial Fibrous Dysplasia

Craniofacial Fibrous Dysplasia Clinical Trial

— CFD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06167122
• Other study ID #: 202000158B0
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: March 14, 2021

Study information

• Verified date: December 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 14, 2021
• Est. primary completion date: February 10, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Craniofacial Fibrous Dysplasia
• Fibrous Dysplasia of Bone
• Hyperplasia

Intervention

Procedure:
• Craniofacial reconstruction
Zone 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Recurrence based on facial bone computed tomography	Personal interviews with facial bone computed tomography obtained on late 2019 and 2020