3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
批准号:
10211825
负责人:
CARROLL ANN TROTMAN
金额:
$67.51万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
已结题
起止时间:
2021-02-16 至 2022-01-31
关键词:
3-DimensionalAffectAgeAnxietyAppearanceAreaBehaviorBotulinum ToxinsCharacteristicsClient satisfactionComputer softwareControl GroupsCustomDataDecision MakingDefectDimensionsDiseaseEstheticsEtiologyEvaluationFaceFacial nerve structureFacial paralysisGoalsGrantHealth Care CostsImageImpairmentIncidenceInterventionLiteratureMeasurementMeasuresMedicalMethodsModelingMovementMuscleNerveObservational StudyOperative Surgical ProceduresOutcomeOutcome AssessmentOutcome StudyParalysedPathologicPatient-Focused OutcomesPatientsPerceptionPersonal SatisfactionPhotographyProcessQuestionnairesRecoveryReportingResearchResolutionSelf PerceptionSeveritiesSmilingSocial InteractionSurgeonSyndromeTestingThree-dimensional analysisTimeTraumaTreatment outcomeTrigeminal nerve structureUnited StatesUnited States National Institutes of Healthbasecleft lip and palatedisabilityfacial disfigurementnerve supplynovelpatient orientedprogramsprospectivereconstructionrepairedsatisfactionsexsoft tissuethree dimensional structurethree-dimensional modelingtreatment planningtumortwo-dimensional
中文摘要
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,特别是面部表情行为。管理需要一个
定制的、有时是不同的方法来矫正面部残疾,包括非手术
面部复活手术的干预措施。外科医生根据 2D 测量结果制定治疗计划
患者面部的图像和主观分级,两者的范围和维度都受到限制。最近,
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,本次展望的总体目标是
观察性研究是比较面部再生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。
将有三组手术患者将接受免费股薄肌移植。第 1 组将有
由三叉神经(nV)驱动的肌肉转移;第 2 组将进行由交叉面驱动的肌肉转移
神经移植物(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转移。的
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。空值
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 拨款); (2)术后5个月和18个月面部残疾的变化
三组; (3) 手术后18个月持续性面部残疾的差异
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)。
具体目标 2. 比较 (1) 面部外观/健康与患者的自我感知差异
三个手术组及对照组术前满意度; (2)自我的改变
手术前至手术后18个月各组的看法; (3)自我差异
手术后 18 个月时手术组和对照组的看法。结果:
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)
目前的主观和二维评估无法提供这一点。结果:3D
面部软组织位移、速度和 3D 毁容(形状)的测量;以及外科医生的主观
eFACE 评级量表的评估和 Face-Gram/Emotrics 软件的 2D 测量。
英文摘要
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.
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会议论文
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
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海外基金