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Completed

NCT Number: NCT06167122

Treatment Protocol and Long-Term Outcomes in Craniofacial Fibrous Dysplasia

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.

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Key information

Conditions

Craniofacial Fibrous Dysplasia Bone Diseases Bone Diseases, Developmental Fibrous Dysplasia of Bone Musculoskeletal Diseases Osteochondrodysplasias

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Craniofacial reconstruction

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.

Primary outcomes

  1. Recurrence

    Time frame: Personal interviews with facial bone computed tomography obtained on late 2019 and 2020

    Recurrence based on facial bone computed tomography

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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

Acronym: CFD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 12, 2023
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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