Side Effects of Cranial Remolding Orthoses: A Multi-Site Review

Infants with deformational head shapes may be treated with a Cranial Remolding Orthosis (CRO). Risks of CROs include skin irritations and other minor side effects. It is important to examine the incidence of complications with CRO treatment to determine if the potential benefits outweigh the risks. This study retrospectively examined surveys provided by both practitioners and caregivers regarding orthotic treatment side effects and wear time at four clinics in Canada. Statistical analysis including the Chi-square test and Fisher's exact tests were performed to examine how the side effects varied by treatment site and by reported orthotic wear time. In total, 5,025 surveys about the CRO treatment of 453 patients were reviewed. The most common side effects were pressure spots, redness lasting for more than 1 hour, excessive sweat, and foul odor; however, the vast majority reported no significant issues (87.08%). Only 2.81% of surveys reported multiple side effects, which was about three times more like to happen when the CRO was reported to have fit problems. Wear time is correlated with the report of side effects; infants who wore the CRO 18 to 23.5 hours had statistically fewer side effects than those who wore the CRO for less time. The reported incidence of side effects may be artificially inflated because infants experiencing side effects are more likely to have more frequent follow-up. Overall, the side effects of CRO treatment reported in this cohort were relatively rare and minimal, indicating CRO treatment is a safe way to treat deformational head shapes.