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: 10353424
• 负责人: CARROLL ANN TROTMAN
• 金额: $ 63.04万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10353424
• 关键词: 3-Dimensional; Affect; Age; Anxiety; Appearance; Area; Behavior; Botulinum Toxins; Characteristics; Client satisfaction; Computer software; Control Groups; Data; Decision Making; Defect; Dimensions; Disease; Disparate; 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; SF-36; Self Perception; Severities; Smiling; Social Interaction; Surgeon; Syndrome; Testing; Three-dimensional analysis; Trauma; Treatment outcome; Trigeminal nerve structure; United States; United States National Institutes of Health; animation; cleft lip and palate; comparison control; 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.

面部麻痹患者具有明显的面部残疾，包括面部毁容和 软组织运动的损害，尤其是面部表达行为。管理需要一个 量身定制的，有时是不同的方法来纠正面部残疾的范围从非手术 面部复活手术的干预措施。基于2D的测量值外科医生的计划治疗 患者脸的图像和主观分级，两者均范围和维度有限。最近， 我们证明了新型，具有里程碑意义的3D动态和静态定量（客观）测量的实用性 以及评估面部瘫痪患者面部残疾的模型比较 他们在12周期间的恢复（NIH DE 025295）。那是这个潜在的总体目标， 观察性研究是比较面部疾病的面部残疾和感知结果 在使用精制3D分析的广泛和永久性单侧瘫痪的患者中，并比较 使用经过验证的问卷调查的面部外观，幸福感和满意度的以患者为中心的结果。 将会有三组手术患者将具有自由的肌肉肌肉转移。第1组将有 由三叉神经驱动的肌肉转移（NV）；第2组的肌肉转移将由横脸驱动 神经移植（NVII）;和第3组将使用两种神经双重神经支配驱动的肌肉。 这些组的数据将与先前收集的历史控制数据进行比较。零 要检验的假设是，手术变化对面部残疾的影响没有差异 （原发性HO）或患者感知（次要HO）受三种不同的手术方法影响 控制患者特征后，面部/微笑复活。 具体目的1。评估（1）手术前的面部残疾（损伤和毁容）的差异 在三个手术组中，并将其与历史对照组进行了比较（在 PRECURSOR R21赠款）; （2）在手术后5到18个月发生的面部残疾变化 三组； （3）手术后18个月的持续性面部残疾差异 组并与对照组进行比较。结果：面部软组织位移，速度的3D测量 和毁容（形式）。 特定目的2。比较（1）面部外观/幸福感和患者的自我感知的差异 手术前三个手术组和对照组的满意度； （2）自我的变化 手术组中手术后的18个月前的看法； （3）自我的差异 手术组和对照组的感知在手术后18个月。结果： 使用面部临床评估量表（FACE）进行定性措施，医学结果研究简短 形式量表（SF-36）和前/术后感知和满意度量表（PSP）。 特定目的3。要比较患者面部残疾的目标，3D，定量评估 外科医生目前对同一患者使用的主观和2D评估，以评估差异 3D评估方法提供的信息（例如受影响的区域，缺陷严重程度以及程度 残疾的解决），目前的主观和2D评估无法获得。结果：3D 面部软组织位移，速度和3D毁容（形式）的度量；和外科医生的主观 来自Eface评级量表和Face-Gram/Emotrics软件的2D措施的评估。