Additive Manufacturing of Spinal Braces: Evaluation of Production Process and Postural Stability in Patients with Scoliosis.

Spinal orthoses produced using additive manufacturing show great potential for obtaining patient-specific solutions in clinical applications, reducing manual operations, time consumption, and material waste. This study was conducted to evaluate the production process of spinal orthoses produced by additive manufacturing, and to test the effects of 3D-printed braces on postural stability in patients with adolescent idiopathic scoliosis and osteogenesis imperfecta. Ten patients were recruited consecutively and were asked to wear a spinal orthosis produced by additive manufacturing for 2 weeks. The four phases of the production process for each brace were evaluated separately on a scale from 0 (not acceptable) to 3 (optimal). Postural stability in the unbraced and the two braced conditions (3D-printed and conventional) was assessed using validated metrics obtained from a wearable inertial sensor. The production process was evaluated as good in four cases, acceptable in five cases, and not acceptable in one case, due to problems in the printing phase. No statistically significant differences were observed in any of the postural balance metrics between the 3D-printed and conventional brace. On the other hand, postural balance metrics improved significantly with both types of braces with respect to the unbraced condition. Spinal orthoses produced with an innovative production process based on digital scans, CAD, and 3D printing are valid alternatives to conventionally produced orthoses, providing equivalent postural stability.