Author/Authors :
Janzing, H. M. J. Department of Surgery - VieCuri Medical Center - Venlo, The Netherlands , Bessems, S. A. M. Department of Surgery - VieCuri Medical Center - Venlo, The Netherlands , Ligthart, M. A. P. Department of Surgery - VieCuri Medical Center - Venlo, The Netherlands , Van Lieshout, E. M. M. Trauma Research Unit Department of Surgery - Erasmus MC - University Medical Center Rotterdam - Rotterdam, The Netherlands , Verhofstad, M. H. J. Trauma Research Unit Department of Surgery - Erasmus MC - University Medical Center Rotterdam - Rotterdam, The Netherlands , Theeuwes, H. P. Department of Surgery - Elisabeth-Tweesteden Hospital - Tilburg, The Netherlands , Barten, D. G. Department of Emergency Medicine - VieCuri Medical Center - Venlo, The Netherlands
Abstract :
The aim of this work was to develop a three-dimensionally (3D) printed brace for the acute treatment
of dorsally dislocated and correctly reduced distal radius fractures (DRF). The hypothesis was that a brace shaped to
the mirror image of the contralateral (non-fractured) wrist will have an optimal anatomical fit, resulting in improved
comfort and lower rates of secondary fracture displacement.
Method: Validation: the circumference of both wrists and comfort of the brace were studied in healthy volunteers
and effectiveness of the brace was evaluated in an ex vivo fracture model.
Clinical study: the brace was tested for comfort and effectiveness in patients with a well reduced unstable DRF.
Results: Validation: the circumference of both wrists may be different, the brace retained the reduction in the
ex vivo fracture model and was well tolerated in the volunteers.
Clinical study: in DRF patients comfort scores were lower and pain scores higher compared to the healthy
volunteers. After 3 and 5 weeks all patients were independent in ADL according to the Katz-index. Posttraumatic
swelling subsided in the first week. In two of the five patients secondary fracture dislocation occurred.
Conclusions: Treatment of a dislocated DRF in the acute setting (day one) with a custom-made 3D printed brace,
anatomically modelled from a 3D scan of the contralateral wrist, is possible. Difference between both wrists and
posttraumatic swelling must be adapted for. The high rate of secondary fracture displacement led to early
discontinuation of the study and a small sample size.
Trial registration: Name of the registry: ClinicalTrials.Gov
Trial registration number: NCT03848702
Date of registration: 02/21/2019, retrospectively registered
Keywords :
RESEARCH , Open Access Treatment , dorsally dislocated distal radius fractures , individualized 3D printed bracing , exploratory study , 3D , Distal radius fractures (DRF)