Three-dimensional Printed Hand Orthoses

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

Status: Completed

Conditions: Hand Injuries and Disorders

Treatments: Device: 3D-printed hand orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05320211

10310012110002

Details and patient eligibility

About

In persons with chronic hand conditions, orthoses are often prescribed to improve daily-life functioning. In most cases, orthoses are custom manufactured based on a plaster hand model, which is a time-consuming and labor-intensive process. It has been demonstrated that the production time to custom manufacture hand orthoses can be greatly reduced by using three-dimensional (3D) scanning and printing, offering a promising cost-effective alternative to conventional costum manufactured hand orthoses. However, before setting up a cost-effectiveness study in persons with chronic hand conditions, insight into the effectiveness of 3D-printed orthoses on performance of activities of daily living (ADL) is needed, as well as insight into potential cost reductions. To date, this information is largely unknown. The aims of this feasibility study are 1) to collect data on the preliminary effectiveness of 3D-printed orthoses on performance of ADL, satisfaction with the orthosis and quality of life compared to conventional orthoses in persons with chronic hand conditions, and 2) to compare the production time and costs of 3D-printed orthoses with conventional orthoses.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Having a chronic hand-wrist condition due to an injury, or a musculoskeletal disorder, neuromuscular disorder, or neurological disorder;
2. Minimum age of 18 years;
3. Currently wearing a conventional custom manufactured hand orthosis (including a wrist-orthosis, wrist/thumb orthosis or thumb orthosis) for permanent use;
4. Indicated for a new hand orthosis.

Exclusion criteria

1. Already wearing a 3D-printed orthosis
2. Wearing a silver wrist-orthosis, wrist/thumb orthosis or thumb orthosis
3. Wearing an orthosis prescribed for a dysfunctional hand;
4. Wearing a broken orthosis;
5. Wearing the orthosis only at night;
6. Worsening of disease;
7. Insufficient mastery of the Dutch language.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

3D-printed hand orthoses

Experimental group

Treatment:

Device: 3D-printed hand orthosis