3D dynamic and patient-centered outcomes of facial reanimation surgery in patients with facial paralysis - patients with facial paralysis have an obvious facial disability that includes facial…

Active Project Grant Awarded Last action

Award ID
R01DE028565
Recipient
Awarding agency
Obligated
$6,990,363

Award facts

Assistance listing
93.121 Oral Diseases and Disorders Research
Completion date 95% complete
Originally
Funding
  • $6,315,283.00 Federal
  • $675,080.00 Non-federal
Place of performance
Columbus, OH 43210, USA

Award details come from USAspending.gov.

Description

3D dynamic and patient-centered outcomes of facial reanimation surgery in patients with facial paralysis - 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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Subawards

Subrecipient Amount Awarded
Massachusetts Eye And Ear Infirmary This study is being conducted to determine differences in outcomes of three different innervations for gracilis muscle transplants for facial reanimation—the… $575,656
University Of Bath The University of Bath will contribute to the analysis of motion capture and functional data. Dr. Faraway will assist Dr. Trotman with the statistical… $123,935
University Of North Carolina At Chapel Hill Dr. Geib Phillips will have responsibility for the primary analyses of patient well-being and psychosocial data, the association between quantitative facial… $75,312

Quick answers

Who received award R01DE028565?

R01DE028565 was awarded to The Ohio State University by National Institute of Dental and Craniofacial Research (National Institutes of Health) on February 1, 2022.

How much is award R01DE028565 worth?

$6,990,363 has been obligated on R01DE028565: $6,315,283 in federal funding and $675,080 in non-federal funding.

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