A Randomized Controlled Trial to Evaluate the Clinical Effectiveness of 3D-Printed Orthosis in the Management of Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Prospective randomized controlled trial. OBJECTIVE: To compare clinical effectiveness and quality of life (QoL) of the 3D-printed orthosis (3O) and conventional orthosis (CO) for adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Using 3D printing technology to design and fabricate orthoses to manage AIS aiming to improve in-orthosis correction and patients' compliance that are considered essential factors of effective treatment. Clinical evaluation was conducted to study the effectiveness of this innovative method. METHODS: Thirty females with AIS who met the criteria (age 10-14, Cobb 20-40°, Risser sign 0-2, ≤12 months after menarche) were recruited. Subjects were randomly allocated to the 3O group (n = 15, age 12.4, Cobb 31.8°) and CO group (n = 15, age 12.0, Cobb 29.3°). All patients were prescribed for full-time wearing (23 hours/d) and follow-up every 4 to 6 months until bone maturity. Compliance was monitored by thermosensors, while QoL was assessed using three validated questionnaires. RESULTS: Comparable immediate in-orthosis correction was observed between 3O (-11.6°, P < 0.001) and CO groups (-12.9°, P < 0.001). In the QoL study via SRS-22r, the 3O group got worse results after 3 months in aspects of function, self-image, and mental health (-0.5, -0.6, -0.7, P < 0.05) while the CO group had worse results in aspects of self-image and mental health (-0.3, -0.3, P < 0.05). No significant difference was found in QoL assessments between groups. After 2 years of follow-up, 22 patients were analyzed with 4 dropouts in each group. Comparable angle reduction was observed in both groups (3O: -2.2°, P = 0.364; CO: -3.5°, P = 0.193). There was one subject (9.1%) in the 3O group while two subjects (18.2%) in the CO group had curve progression >5°. Daily wearing hours were 1.9 hours longer in the 3O group than the CO group (17.1 vs. 15.2 hours, P = 0.934). CONCLUSION: The 3O group could provide comparable clinical effects as compared with the CO group while patients with 3O showed similar compliance and QoL compared to those with CO.Level of Evidence: 1.