3D-Printed spinal orthosis in management of adolescent idiopathic scoliosis: a randomized controlled trial

Abstract

Summary: A randomized controlled trial between conventional and 3D-printed orthoses for adolescent idiopathic scoliosis (AIS) was conducted. No differences in Cobb angle were observed between groups. 3D-printed orthoses led to improved BrQ scores and improved compliance. Hypothesis: 3D-printed spinal orthoses are equal in effectiveness to fabricated orthoses with increased patient acceptance. Design: Randomized controlled trial. Introduction: With the recent advancements in the computer-aided manufacture, 3D printing technology can be applied for more versatile fabrication of spinal orthoses such as reduced weight and thickness. This may enhance brace compliance and subsequent treatment outcomes. The application of 3D printing technology in orthotic treatment requires study to confirm its clinical effectiveness and patient’s acceptance. Thus, this study aimed to investigate the clinical effectiveness of 3D-printed spinal orthoses and its patient’s acceptance. Methods: A randomized controlled trial was conducted on 30 patients with moderate AIS (Cobb 25-45°). Equal number of patients were randomly assigned to 3D-printed orthoses (3O) with mean age of 12.3 and Cobb 32.7° or the conventional orthoses (CO) with mean age of 12.5 and Cobb 29.6°. The patients’ quality of life was assessed using the SRS-22, TAPS, BrQ at the baseline, 1-month and 3-month of orthotic treatment. Thermal sensors were used to measure compliance. The immediate in-orthosis X-ray was used for correction analysis. Results: All patients completed the follow-up without dropouts. There were no significant differences in terms of SRS-22 or Cobb angle correction. Comparable in-orthosis correction was observed between the 3O group (12.2°, 36.8%, p<0.01) and CO group (13.1°, 44.7%, p=0.01).The results of BrQ school activity was 10.4 significantly higher in the 3O group at the 1-month follow-up (88.0 vs. 77.6, p<0.05). Daily wearing hours was 0.3 slightly longer in the 3O group than the CO group (17.2 vs. 16.9 hrs). Conclusion: 3D-printed orthoses, which were lighter and thinner in design, provided similar clinical effectiveness with improved patient perceived outcomes and brace compliance. Longer-term follow-up is needed to observe for any further changes in compliance and quality of life measures.