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3D Hand Orthosis Trial
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Summary
In people with chronic hand conditions, hand orthoses are frequently prescribed to improve performance in activities of daily living (ADL). Conventional hand orthoses are custom-made on a plaster cast of the hand, a process that is time-consuming and labor-intensive. It has been demonstrated that the production time of manufacturing hand orthoses can be reduced by using 3-dimensional scanning and printing (i.e. 3D-printed hand orthosis), offering a promising cost-effective alternative to conventional hand orthoses. The current study builds on a previously conducted feasibility study, which demonstrated comparable effects of 3D-printed and conventional hand orthoses on ADL performance, hand function, and quality of life in people with chronic hand conditions. User satisfaction and production time favored the 3D-printed orthoses. However, to date only small and self-controlled studies have investigated the effects of 3D-printed versus conventional hand orthoses for permanent use on ADL performance and orthosis satisfaction in chronic hand conditions. Evidence from randomized controlled trials and data on the cost-effectiveness are lacking. The aims of this study are: 1. To determine whether treatment with 3D-printed hand orthoses is non-inferior compared to treatment with conventional hand orthoses in terms of ADL performance, hand function, pain, quality of life and functional status in individuals with chronic hand conditions. 2. To assess whether treatment with 3D-printed hand orthoses results in greater patient satisfaction compared to treatment with conventional hand orthoses. 3. To assess the cost-effectiveness of treatment with 3D-printed hand orthoses compared to treatment with conventional hand orthoses.
Official title: Cost-effectiveness of 3D-printed Hand Orthoses for Activities of Daily Living in Chronic Hand Conditions
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-09-14
Completion Date
2030-09
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
3D-printed hand orthosis (intervention)
3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control)
Conventional hand orthosis (control)
3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional hand orthoses (control)
Locations (1)
Amsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands