ABSTRACT
BACKGROUND: Utilization of point-of-care 3-dimensional printing (3DP) has decreased length of surgery in facial trauma. Little is known regarding 3DP's impact on length of surgery in orbital fracture. PURPOSE: The purpose of this study was to compare length of surgery between 3DP/preadapted (3DPPA) orbital plates and intraoperative adapted plates (IOAP) for orbital fracture reconstruction. STUDY DESIGN, SETTING, SAMPLE: This was a prospective, non-blinded, randomized clinical study of consecutive subjects with orbital fractures presented to Grady Memorial Hospital in Atlanta, Georgia, between January 2018 and June 2021. Subjects ≥ 18 years, unilateral fracture, no previous orbital surgery, and/or congenital craniofacial anomaly were included. We excluded subjects <18 years and bilateral fractures. PREDICTOR/EXPOSURE/INDEPENDENT VARIABLE: Primary predictor variable was the treatment approach. Randomization software was used, and subjects were randomized to 3DPPA or IOAP groups. MAIN OUTCOME VARIABLE(S): Primary outcome variable was length of surgery in minutes. Secondary outcomes were the time required for plate insertion and fixation in minutes, operating room (OR) charges, and orbital volume (OV) calculation. COVARIATES: Age, sex, race, etiology, laterality, location, dimension, indication for surgery, postoperative enophthalmos, and diplopia. ANALYSES: Univariate and bivariate analyses were calculated. Statistical significance was P < .05. RESULTS: Twenty-five subjects met the inclusion criteria. Mean ages in 3DPPA and conventional IOAP groups were 41.5 (±9) and 38.2 (±10, P = .31), respectively. The mean length of surgery was 32.6 (±13.7) in 3DPPA and 53.3 (±12.8, P < .001) in conventional IOAP. The mean time required for plate insertion and fixation was 15.8n (±14.4) in 3DPPA and 41.4 (±9.4, P < .001) in conventional IOAP. The mean OR charges were $1,072.5 (±524.6) in 3DPPA and $1,757.3 (±422.6, P ≤ 0.001) in conventional IOAP. The mean calculated OV of uninjured and reconstructed orbit for the 3DPPA was 23.5 (±3.2)cm3 and 23 (±3.5, P = .37)cm3, respectively. The mean calculated OV of uninjured and reconstructed orbit for conventional IOAP was 28.6 (±3.6)cm3 and 22.8 (±2.6, P < .001)cm3, respectively. CONCLUSION AND RELEVANCE: Using 3DP to produce a model that enables preoperative plate bending/adaptation reduces the length of surgery, decreases OR charges, and results in predictable OV.