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Treatment Protocol and Long-Term Outcomes in Craniofacial Fibrous Dysplasia

NCT ID: NCT06167122

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-03-14

Brief Summary

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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

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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

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Craniofacial Fibrous Dysplasia

Keywords

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Craniofacial fibrous dysplasia Optic nerve decompression Hormone therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Craniofacial fibrous dysplasia

Fibro-osseous lesions within the affected bones based on image, and surgical intervention based on 4 different anatomical zones.

Craniofacial reconstruction

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pangyunchou

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pang-Yun Chou

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202000158B0

Identifier Type: -

Identifier Source: org_study_id