Preliminary effectiveness of 3D-printed orthoses in chronic hand conditions: study protocol for a non-randomised interventional feasibility study

Abstract

IntroductionHand orthoses are often provided to improve performance of activities of daily life (ADL). Yet, the manufacturing process of conventional custom-fabricated hand orthoses is a time-consuming and labour-intensive process. Even though three-dimensional (3D) printing of orthoses is a rapidly growing area that can facilitate the manufacturing process of hand orthoses, evidence on the effectiveness, costs and production time of 3D-printed orthoses in chronic hand conditions is scarce. This study aims to assess (1) the preliminary effectiveness of 3D-printed orthoses compared with conventionally custom-fabricated orthoses in persons with chronic hand conditions, (2) production time and costs of both orthoses and (3) experiences of the participants and orthotists with the manufacturing process of the 3D-printed orthosis.Methods and analysisIn this prospective non-randomised interventional feasibility study, 20 adults with various chronic hand conditions using a conventional thumb, wrist or wrist-thumb orthosis will be provided with a 3D-printed corresponding type of orthosis. Assessments will be done 2 weeks prior to the intervention and at baseline for the conventional orthosis, and at 1 month and 4 months follow-up for the 3D-printed orthosis. The primary outcome is change from baseline in ADL performance (custom short form Dutch-Flemish Patient-Reported Outcomes Measurement Information System-Upper Extremity; ADL domain Michigan Hand Outcomes Questionnaire Dutch language version (MHQ-DLV)) at 4 months follow-up. Secondary outcomes include general hand function (MHQ-DLV), satisfaction with the orthosis (Dutch Client Satisfaction with Device; Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology), usability (in-house questionnaire) and quality of life (EuroQoL 5-Dimension 5-Level). Costs and production time of the conventional and 3D-printed orthoses will be prospectively recorded. Experiences regarding the manufacturing process will be obtained from participants and orthotists (in-house questionnaire).Ethics and disseminationThe Medical Ethics Committee of the Amsterdam UMC, Academic Medical Centre, has waived the requirement for ethical review of this study. Results will be disseminated through peer-reviewed journals, scientific conferences, and media aimed at a broad audience including patients.Trial registration numberNCT05320211.

Preliminary effectiveness and production time and costs of three-dimensional printed orthoses in chronic hand conditions: an interventional feasibility study

“…Further, production time and costs were measured for both orthoses, as well as the experiences of participants and orthotists with the 3D-printing intervention. Descriptions of the secondary outcomes have been provided in the protocol article ( 16 ). A more detailed description of the assessment of orthosis satisfaction and production time and costs is given below.…”

“…Contrary to the study protocol ( 16 ), we did not pool the results of the conventional orthosis obtained 2 weeks prior to the intervention (T1) and at baseline (T2), as it appeared that there was an anticipation effect in 2 out of 3 outcome measures (DF-PROMIS-UE: mean difference T2 vs T1: –1.6, p = 0.007; D-CSD: mean difference T2 vs T1: –2.1, p = 0.04). Therefore, we compared baseline (T2) data with those at 1 month (T3) and 4 months’ (T4) follow-up.…”

Exploring a Novel Material and Approach in 3D-Printed Wrist-Hand Orthoses

“…An observed negative reaction associated with these rigid materials is the development of pressure sores or skin 2 of 17 redness [4]. However, effective clinical outcomes and patient preference for an aesthetically pleasing design and lightweight construction achieved through the incorporation of open pockets of varied shapes and dimensions have been reported [5,6]. These features also contribute to enhanced hygiene and ventilation and facilitate the observation of the skin's status [4][5][6].…”

A Review on 3D Scanners Studies for Producing Customized Orthoses

“…An important requirement for orthoses is comfort, which is attained through a high level of customization facilitated by an accurate capture of the patient’s anatomy [ 7 , 8 ]. Given that each patient possesses a unique body geometry, custom-made orthoses have emerged as the “gold standard”, since the geometry of the orthosis is individually adapted for each patient [ 9 , 10 ]. The journey towards acquiring a custom-made orthosis entails several stages including scanning (digitization), importing the scanned data into a computer to create a computer-aided design (CAD) file, modelling, topological optimization, and 3D printing [ 11 , 12 , 13 , 14 ].…”