跳至主要内容
临床试验/NCT07305909
NCT07305909已完成不适用

Two- and Three-Dimensional Quantification of Facial Symmetry Following Fat Grafting Versus Free Flap Reconstruction in Hemifacial Atrophy: A Retrospective Observational Study

Peking Union Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Change in 2D Facial Symmetry Ratio

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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
  • Availability of standardized preoperative assessment and postoperative assessment at the first follow-up visit occurring ≥6 months after surgery (2D photographs required).

排除标准

  • 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.

结局指标

主要结局

Change in 2D Facial Symmetry Ratio

时间窗: Baseline (preoperative) and first follow-up visit 6 months postoperatively

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.

次要结局

  • Change in 3D Volumetric Discrepancy Between Hemifaces(Baseline (preoperative) and first follow-up visit 6 months postoperatively)

研究者

发起方
Peking Union Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaolei Jin

Chief Physician, Professor of Plastic Surgery

Peking Union Medical College

研究点 (1)

Loading locations...

相似试验