Impact of Age on Success of 3D-Printed Cranial Remolding Orthoses for Deformational Head Shapes

Background/Objectives: Previous studies regarding the efficacy of cranial remolding orthoses (CROs) have shown that earlier treatment initiation is associated with more favorable outcomes, but there are few studies utilizing 3D-printed CROs. This study evaluated the impact of treatment initiation age on the success of 3D-printed CROs in terms of morphological measurement changes and caregiver satisfaction. Methods: A total of 1054 infants who initiated treatment with a 3D-printed CRO during 2023 across six pediatric clinics in Canada were included in this retrospective cohort study. Participants were stratified by treatment initiation age (<6 months, 6-9 months, and 9-12 months) and deformational head shape: deformational plagiocephaly (DP), deformational brachycephaly (DB), or deformational asymmetric brachycephaly (DAB). Results: Relevant pre-treatment measurements for DP were CVAI = 7.98 ± 2.30, for DB were CR = 97 ± 4%, and DAB were CVAI = 7.22 ± 2.21 and CR = 95 ± 3%. All head shapes improved during treatment and overall caregiver satisfaction was high (94.4%). A total of 66.89% of participants achieved full correction of their cranial deformation (CR ≤ 90% and CVAI < 3.5), with the highest correction observed among the youngest infants for each head shape type. Cranial correction rates were highest for DP (76.85%), followed by DAB (57.73%) and DB (54.68%). The mean correction rate varied greatly between treatment initiation age and deformation type subgroups (21.74% to 82.73%). Conclusions: Treatment with 3D-printed CROs resulted in measurement improvement across all participants and caregiver satisfaction remained high. Earlier treatment initiation was associated with significantly better correction rates, supporting early referral and intervention whenever possible. These findings provide evidence to inform clinical recommendations and support caregivers in making decisions regarding treatment for cranial deformation and appear akin to the findings of studies utilizing traditionally fabricated CROs.