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

基本信息

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
项目类别：
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

项目摘要

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，包括面部毁容和软组织运动受损，尤其是面部表情行为受损，需要进行管理。定制的、有时是不同的方法来矫正面部残疾，包括非手术外科医生根据 2D 测量结果制定治疗计划。最近，患者面部的图像和主观分级在范围和维度上都受到限制。我们展示了新颖的、基于地标的、3D 动态和静态定量（客观）测量的实用性面瘫患者面部残疾评估和模型比较并跟踪他们在 12 周内恢复（NIH DE 025295）因此，该前瞻性的总体目标，观察性研究是比较面部复活手术的面部残疾和感知结果使用精细 3D 分析对患有广泛且永久性单侧瘫痪的患者进行研究，并进行比较使用经过验证的问卷调查以患者为中心的面部外观、幸福感和满意度结果。将有三组手术患者进行免费股薄肌移植，第一组将进行免费的股薄肌移植。由三叉神经 (nV) 驱动的肌肉转移；第 2 组将有由十字面驱动的肌肉转移；神经移植（nVII）；第 3 组将使用两条神经进行由双重神经支配驱动的肌肉移植。来自这些组的数据将与之前从历史对照中收集的数据进行比较。要检验的假设是手术改变对面部残疾的影响不会有差异（主要 HO）或受三种不同手术方法影响的患者感知（次要 HO）控制患者特征后面部/微笑复活。具体目标 1. 术前评估 (1) 面部残疾（损伤和毁容）的差异在三个手术组之间进行比较，并与历史对照组（在手术期间收集的控制数据）进行比较前体R21补助金）；（2）术后5个月和18个月时面部残疾的变化三组；（3）手术后18个月持续性面部残疾的差异结果：面部软组织位移、速度的 3D 测量。和毁容（形式）。具体目标 2. 比较 (1) 面部外观/健康与患者的自我感知差异三个手术组与对照组术前的满意度变化；手术前至术后18个月各组的认知差异；(3)自我差异；手术后 18 个月时手术组和对照组的看法：使用面部临床评估量表 (FACE) 进行定性测量，医疗结果研究短片形态量表 (SF-36) 和手术前/术后感知和满意度量表 (PSP)。具体目标 3. 将患者面部残疾的客观、3D、定量评估与外科医生目前对同一患者使用主观和二维评估，以评估差异 3D 评估方法提供的信息（例如受影响的面积、缺陷的严重程度以及缺陷的程度）当前主观和 2D 评估无法提供的解决方案：3D。面部软组织位移、速度和 3D 毁容（形式）和外科医生主观的测量； eFACE 评级量表的评估和 Face-Gram/Emotrics 软件的 2D 测量。