Improving facial prosthesis construction with a contactless scanning and digital workflow: A feasibility crossover randomized controlled trial of digital versus conventional manufacture of orbital and nasal prostheses

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STATEMENT OF PROBLEM: Research is needed to compare the clinical and cost effectiveness of the digital and conventional manufacturing of facial prostheses. Feasibility trials can help acquire the data needed to plan a definitive randomized controlled trial (RCT). PURPOSE: The purpose of this clinical study was to assess the feasibility of conducting a future definitive RCT of the clinical and cost effectiveness of the digital versus conventional manufacture of facial prostheses in patients with orbital or nasal defects. The primary objective was to assess eligibility, recruitment, conversion, and attrition rates. Secondary objectives included synthesizing data on outcomes for a definitive trial. MATERIAL AND METHODS: A multicenter feasibility crossover RCT compared the digital and conventional manufacture of facial prostheses at Leeds Teaching Hospitals NHS Trust and Guy's and St Thomas' NHS Foundation Trust between December 2021 and October 2023. Patients over 16 years of age were eligible if they had acquired orbital or nasal defects and required a replacement facial prosthesis. Centralized allocation used minimization to allocate participants to 2 groups which differed in the order of receiving the intervention and control prostheses. Participants were masked to the manufacturing method by marking the prostheses with color labels. Data were collected on patient flow and the planned outcomes for a definitive RCT (participant preference, generic and condition specific health related quality of life, and costs from the healthcare perspective). Data were analyzed descriptively and narratively. RESULTS: Fifteen participants were recruited and allocated to receive the intervention (n=7) or the control prosthesis (n=8) first. Analysis of the primary outcomes identified 100% eligibility, 88% recruitment, 100% conversion, and 27% attrition rates. Analysis of secondary outcomes showed the mean ±standard deviation Toronto Outcome Measure for Craniofacial Prosthetics-27 score was 59 ±26% at baseline; the change from baseline was 10 ±14% for the intervention and 13 ±16% for the control. The mean EQ-5D-5L index score was 0.72 ±0.24 at baseline; the change from baseline was 0.07 ±0.12 for the intervention and 0.02 ±0.12 for the control. CONCLUSIONS: A definitive study was determined to be feasible. A recommendation for progression has been made with some modifications to study design.

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