- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07305909
Two- and Three-Dimensional Quantification of Facial Symmetry After Fat Grafting and Free Flap Reconstruction in Hemifacial Atrophy
Two- and Three-Dimensional Quantification of Facial Symmetry Following Fat Grafting Versus Free Flap Reconstruction in Hemifacial Atrophy: A Retrospective Observational Study
Hemifacial atrophy causes one side of the face to become smaller, leading to facial asymmetry. Surgeons often restore facial volume using either autologous fat grafting or free-flap reconstruction. However, it is not fully clear how much facial symmetry improves after surgery when measured objectively using two-dimensional (2D) photographs and three-dimensional (3D) surface scans.
This is a single-center, retrospective observational study of patients with hemifacial atrophy treated between January 2020 and December 2023 at [Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College]. We will quantify facial symmetry before surgery and at the first follow-up visit occurring at or beyond 6 months after the initial surgery. Symmetry outcomes will be assessed using standardized 2D photographs for all included patients, and 3D surface scans for a subset of patients. Complications will also be assessed at the first ≥6-month follow-up visit. We will compare changes in symmetry between patients treated with fat grafting and those treated with free-flap reconstruction.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100144
- Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Diagnosis of hemifacial atrophy (Parry-Romberg syndrome).
Underwent initial soft-tissue augmentation with either autologous fat grafting or free-flap reconstruction at the study center between January 2020 and December 2023.
Availability of standardized preoperative assessment and postoperative assessment at the first follow-up visit occurring ≥6 months after surgery (2D photographs required).
Exclusion Criteria:
Follow-up <6 months after the initial surgery.
Missing key imaging/photographic data required for outcome assessment.
Any additional facial augmentation or revision procedure performed before the first ≥6-month follow-up visit.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Fat Grafting
Patients with hemifacial atrophy who underwent autologous fat grafting as the initial soft-tissue augmentation procedure.
Outcomes were assessed preoperatively and at the first follow-up visit occurring ≥6 months postoperatively.
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Free Flap Reconstruction (ALT)
Patients with hemifacial atrophy who underwent anterolateral thigh (ALT) free-flap reconstruction as the initial soft-tissue augmentation procedure.
Outcomes were assessed preoperatively and at the first follow-up visit occurring ≥6 months postoperatively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in 2D Facial Symmetry Ratio
Time Frame: Baseline (preoperative) and first follow-up visit 6 months postoperatively
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Facial symmetry ratio calculated from standardized frontal 2D photographs using computerized photogrammetric analysis.
The primary endpoint is the change from preoperative baseline to the first postoperative follow-up visit occurring at or beyond 6 months after the initial surgery.
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Baseline (preoperative) and first follow-up visit 6 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in 3D Volumetric Discrepancy Between Hemifaces
Time Frame: Baseline (preoperative) and first follow-up visit 6 months postoperatively
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Three-dimensional (3D) volumetric discrepancy between the affected and unaffected hemiface measured from 3D surface scans in the subset of participants with available 3D data.
Change from baseline to the first ≥6-month follow-up visit.
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Baseline (preoperative) and first follow-up visit 6 months postoperatively
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-344 (Other Identifier: Institutional Review Board of the Plastic Surgery Hospital, Chinese Academy of Medical Sciences)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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