ArticleHand therapy2026
Study protocol for a pilot randomized crossover trial: Comparing the clinical utility, feasibility, and patient outcomes of remote 3D-printed orthosis fabrication using an innovative heat-reshapable PCL.
Article in Hand therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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4 authors.
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Abstract
Introduction: Orthotic fabrication is a widely used option of the conservative management of carpometacarpal (CMC) osteoarthritis, where conventional low-temperature thermoplastic orthosis requires in-person expertise and adjustments, which limit access to care. Advances in 3D printing and smartphone-based scanning offer opportunities for remote orthosis fabrication. However, the feasibility, accuracy, and patient outcomes compared with traditional methods remain unclear. Methods: This randomized crossover pilot trial will compare remote 3D-printed orthoses, fabricated using a novel heat re-shapable polycaprolactone (PCL), with conventionally fabricated thermoplastic orthoses in 40 hands with early-stage CMC osteoarthritis. Each participant will receive both interventions in a random order, separated by a 1-week washout period. Outcomes include pain (measured using the Numerical Rating Scale), function (assessed using the QuickDASH), adherence, satisfaction, and clinical utility (evaluated using the QUEST and qualitative interviews). Technical parameters (fabrication time, material properties, weight, and need for adjustments) and the feasibility of smartphone versus high-precision photogrammetry scanning will also be evaluated. Results: As a pilot study, outcomes will focus on feasibility benchmarks (recruitment, retention, adherence) and variability estimates to inform sample size calculations for a definitive trial. Preliminary comparisons of pain, function, and satisfaction between orthosis types, as well as the usability of smartphone scanning and the adaptability of heat re-shapable PCL, will be reported. Discussion/Conclusion: This study will provide the first clinical evidence on the feasibility and patient-centred utility of remote orthosis fabrication using an innovative heat re-shapable 3D printing material. Findings will inform whether digital workflows can extend access to hand therapy and support larger-scale trials to evaluate clinical effectiveness and long-term outcomes.
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