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NCT05320211

Three-dimensional Printed Hand Orthoses

Completed NA Last updated 31 March 2023
What this trial tests

NA trial testing 3D-printed hand orthosis in Hand Injuries and Disorders in 21 participants. Completed in 28 February 2023.

Timeline
12 April 2022
Primary endpoint
28 February 2023
28 February 2023

Quick facts

Lead sponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment21
Start date12 April 2022
Primary completion28 February 2023
Estimated completion28 February 2023
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

18 and older, any sex, with Hand Injuries and Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Preliminary effectiveness of 3D-printed orthoses in chronic hand conditions: study protocol for a non-randomised interventional feasibility study.
    Oud T, Tuijtelaars J, Bogaards H, Nollet F, et al · · 2023 · cited 6× · PMID 37024252 · DOI 10.1136/bmjopen-2022-069424
  2. Validity and reliability of the Dutch translation of the OPUS' client satisfaction with device module in chronic users of hand orthoses.
    Oud T, Tuijtelaars J, Schenk J, Nollet F, et al · · 2023 · cited 3× · PMID 37605151 · DOI 10.1186/s12955-023-02181-3
  3. Preliminary effectiveness and production time and costs of three-dimensional printed orthoses in chronic hand conditions: an interventional feasibility study.
    Oud T, Bogaards JA, Nollet F, Brehm MA. · · 2024 · cited 1× · PMID 38742877 · DOI 10.2340/jrm.v56.39946

Verify or expand the search:

Other recruiting trials for Hand Injuries and Disorders

Currently open trials in the same condition.

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

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05320211.

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