Acceptability and safety of 3D printed wrist-based orthoses compared to fiberglass casts for the treatment of non-surgical distal radius- and scaphoid fractures: A randomized feasibility trial.

Abstract

Background: Non-invasiveness and comfort are crucial in the conservative management of distal radius and scaphoid fractures. While fiberglass casts are standard, three-dimensional (3D)-printed orthoses offer a promising alternative.

Purpose: To compare patient experiences, safety perceptions, and satisfaction between a 3D orthosis and fiberglass cast for distal radius or scaphoid fractures.

Study design: Randomized feasibility trial.

Methods: Nineteen adult patients were randomly assigned (3D orthosis group, n = 10; fiberglass cast group, n = 9) and followed until orthosis or cast removal at 6-8 weeks. X-rays at weeks 1 and 6 documented bone healing, with weekly hand therapy visits assessed orthosis satisfaction and function. The Patient-Rated orthosis Satisfaction Questionnaire (PRSEQ) measured satisfaction at weeks 2, 4, and removal. Descriptive statistics and non-parametric correlation tests were used for data analysis.

Results: The 3D orthosis group achieved significantly higher PRSEQ scores (mean difference [MD]= 15.7%, p = 0.005 to 0.01, r = -.581 to -.638) and lower perceived pain (MD=-1.0 to -2.2, p = 0.001 to 0.048, r = -0.45 to -0.75) compared to the cast group. By week 4, the 3D group reported less discomfort (MD=-2.2, p = 0.03, r = -0.5) and felt safer (MD=1.6, p = 0.043, r = -0.46). Routine activities were easier for the 3D group at weeks 2 and 6 (MD=-2.8 to -3.0, p = 0.033 to 0.034, r = -0.49). Satisfaction scores were higher in the 3D group (mean 8.4 vs. 5.6 points, p < 0.001 to 0.01, r = -0.57 to -0.82). Compliance was excellent in both groups. No significant differences were observed in radiological outcomes, finger sensibility, or edema. Bone healing occurred in both groups without fracture displacement; however, one cast patient required subsequent surgery for scaphoid non-union.

Conclusions: Treatment with a 3D-printed orthosis appeared feasible and safe, with patients reporting higher satisfaction and better self-perceived hand function compared to a custom-made fiberglass cast, although further research is needed to confirm these findings.