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3D Hand Orthosis Trial

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Start date changed from estimate of Jun 2026 to Sep 14, 2026 · Secondary endpoints: details revised at 10 of 10 entries · Site details revised · 2 more Show 5 more changesShow less
    • Start date changed from estimate of Jun 2026 to Sep 14, 2026
    • Secondary endpoints: details revised at 10 of 10 entries
    • Site details revised
    • Publications: details revised at 5 of 5 entries
    • Eligibility criteria expanded, about 5 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07633821
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Conditions Hand Injuries and Disorders, Neurological Conditions, Neuromuscular Diseases (NMD), Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis)
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov