3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis

面瘫患者面部复活手术的 3D 动态和以患者为中心的结果

• 批准号: 10211825
• 负责人: CARROLL ANN TROTMAN
• 金额: $ 67.51万
• 依托单位: TUFTS UNIVERSITY BOSTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-16 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10211825
• 关键词: 3-Dimensional; Affect; Age; Anxiety; Appearance; Area; Behavior; Botulinum Toxins; Characteristics; Client satisfaction; Computer software; Control Groups; Custom; Data; Decision Making; Defect; Dimensions; Disease; Esthetics; Etiology; Evaluation; Face; Facial nerve structure; Facial paralysis; Goals; Grant; Health Care Costs; Image; Impairment; Incidence; Intervention; Literature; Measurement; Measures; Medical; Methods; Modeling; Movement; Muscle; Nerve; Observational Study; Operative Surgical Procedures; Outcome; Outcome Assessment; Outcome Study; Paralysed; Pathologic; Patient-Focused Outcomes; Patients; Perception; Personal Satisfaction; Photography; Process; Questionnaires; Recovery; Reporting; Research; Resolution; Self Perception; Severities; Smiling; Social Interaction; Surgeon; Syndrome; Testing; Three-dimensional analysis; Time; Trauma; Treatment outcome; Trigeminal nerve structure; United States; United States National Institutes of Health; base; cleft lip and palate; disability; facial disfigurement; nerve supply; novel; patient oriented; programs; prospective; reconstruction; repaired; satisfaction; sex; soft tissue; three dimensional structure; three-dimensional modeling; treatment planning; tumor; two-dimensional

Patients with facial paralysis have an obvious facial disability that includes facial disfigurement and impairment in soft tissue movements, particularly in facial expressive behaviors. Management requires a tailored and, at times, disparate approach to correct the facial disability ranging from non-surgical interventions to facial reanimation surgery. Surgeons’ plan treatment based on measurements made from 2D images and subjective grading of the patient’s face, both of which are limited in scope and dimension. Recently, we demonstrated the utility of novel, landmark-based, 3D dynamic and static quantitative (objective) measures and modeling comparisons for the evaluation of facial disability in patients with facial paralysis and tracked their recovery over a 12-week period (NIH DE 025295). Thus, the overall goal of this prospective, observational study is to compare the facial disability and perception outcomes of facial reanimation surgeries in patients with extensive and permanent, unilateral paralysis using the refined 3D analysis, and compare patient-centered outcomes of facial appearance, well-being, and satisfaction using validated questionnaires. There will be three groups of surgery patients who will have a free gracilis muscle transfer. Group 1 will have muscle transfer driven by the trigeminal nerve (nV); Group 2 will have muscle transfer driven by a cross-face nerve graft (nVII); and Group 3 will have muscle transfer driven by dual innervation using both nerves. The data from these groups will be compared with previously collected data from historical controls. The null hypothesis to be tested is that there will be no difference in the impact of the surgical change on facial disability (primary HO) or on patient perception (secondary HO) effected by the three different surgical approaches for facial/smile reanimation after controlling for patient characteristics. Specific Aim 1. To assess (1) the differences in facial disability (impairment and disfigurement) before surgery among the three surgery groups and compared to a historical control group (control data collected during the precursor R21 grant); (2) the changes in facial disability that occur at 5 and 18 months after surgery among the three groups; and (3) the differences in persistent facial disability 18 months after surgery among the surgery groups and compared to the control group. Outcomes: 3D measures of facial soft tissue displacement, velocity, and disfigurement (form). Specific Aim 2. To compare (1) the differences in self-perceptions of facial appearance/well-being and patient satisfaction among the three surgery groups and control group before surgery; (2) the changes in self perceptions from before to 18 months after surgery among the surgery groups; and (3) the differences in self perceptions among the surgery groups and the control group at 18 months after surgery. Outcomes: Qualitative measures using the Facial Clinimetric Evaluation Scale (FACE), Medical Outcomes Study Short Form Scale (SF-36) and the Pre/Postsurgical Perception and Satisfaction Scale (PSP). Specific Aim 3. To compare the objective, 3D, quantitative assessments of patients’ facial disability with surgeons’ currently used subjective and 2D assessments for the same patients in order to assess the differential information provided by the 3D assessment approach (such as area affected, severity of defect, and extent of resolution of disability) that is not available from the current subjective and 2D assessments. Outcomes: 3D measures of facial soft tissue displacement, velocity, and 3D disfigurement (form); and surgeons’ subjective assessments from eFACE rating scale and 2D measures from Face-Gram/Emotrics software.

面瘫患者有明显的面部残疾，包括面部毁容， 软组织运动障碍，特别是面部表达行为。管理需要 量身定制，有时，不同的方法来纠正面部残疾，从非手术 面部复苏手术的干预措施。外科医生根据2D测量结果制定治疗计划 图像和患者面部的主观分级，这两者在范围和尺寸上都是有限的。最近， 我们展示了新颖的、基于地标的、三维动态和静态定量（客观）测量的效用 面神经麻痹患者面部功能障碍的评估和跟踪建模比较 在12周内恢复（NIH DE 025295）。因此，这一前瞻性的总体目标， 一项观察性研究是比较面部复苏手术的面部残疾和感知结果 在广泛性和永久性单侧瘫痪患者中，使用精确的3D分析，并比较 以患者为中心的面部外观，幸福感和满意度的结果，使用有效的问卷。 将有三组手术患者谁将有一个自由股薄肌移植。第1组将有 由三叉神经（nV）驱动的肌肉转移;第2组将进行由十字面驱动的肌肉转移 神经移植物（nVII）;组3将具有通过使用两条神经的双神经支配驱动的肌肉转移。的 将来自这些组的数据与先前收集的来自历史对照的数据进行比较。零 有待检验的假设是，手术改变对面部残疾的影响没有差异 （原发性HO）或受三种不同手术入路影响的患者感知（继发性HO）， 在控制患者特征后的面部/微笑恢复。 具体目标1.评估（1）术前面部残疾（损伤和毁容）的差异 并与历史对照组（在手术期间收集的对照数据）进行比较。 前体R21补助金）;（2）面部残疾的变化，发生在手术后5个月和18个月之间， 三组;（3）手术后18个月持续性面部残疾的差异 并与对照组进行比较。结果：面部软组织位移、速度、 （一）形式（form）。 具体目标2。比较（1）面部外观/幸福感的自我感知和患者 术前三组患者及对照组患者的满意度;（2）术前三组患者的自我变化 手术组术前至术后18个月的自我感觉;（3）自我感觉的差异 术后18个月时，手术组和对照组之间的感知。成果： 使用面部临床评价量表（FACE）进行定性测量，医学结局研究（短） 形式量表（SF-36）和术前/术后感知和满意度量表（PSP）。 具体目标3。比较患者面部残疾的客观、3D、定量评估， 外科医生目前对同一患者使用主观和2D评估，以评估 3D评估方法提供的信息（如受影响的区域、缺陷的严重程度和 残疾的解决），这是目前的主观和2D评估不可用。结局：3D 面部软组织位移、速度和3D缺陷（形式）的测量;以及外科医生的主观 使用eFACE评定量表进行评估，使用Face-Gram/Acetrics软件进行2D测量。