3D Hand Orthosis Trial

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.

Conditions

• Hand Injuries and Disorders
• Neurological Conditions
• Neuromuscular Diseases (NMD)
• Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis)

Interventions

DEVICE

3D-printed hand orthosis (intervention)

3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control)

DEVICE

Conventional hand orthosis (control)

3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional hand orthoses (control)

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Principal Investigators

• Merel-Anne Brehm, PhD · Amsterdam UMC, location AMC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2030-05-31

Completion

2030-09-30

Countries

• Netherlands

Study Locations