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NCT05320211
Three-dimensional Printed Hand Orthoses
NA trial testing 3D-printed hand orthosis in Hand Injuries and Disorders in 21 participants. Completed in 28 February 2023.
28 February 2023
Quick facts
| Lead sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 12 April 2022 |
| Primary completion | 28 February 2023 |
| Estimated completion | 28 February 2023 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- 3D-printed hand orthosis
Conditions studied
- Hand Injuries and Disorders — all drugs for Hand Injuries and Disorders →
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):
-
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 -
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 -
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:
- PubMed search for NCT05320211
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05320211 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Last refreshed: 31 March 2023
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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