Background <p>Distal radius fractures (DRF) are often immobilized using a conventional plaster cast although orthoses offer a time- and resource-saving alternative. This prospective randomized study compared the conservative DRF treatment using an orthosis (OPTIVOhand^®) with plaster cast immobilization. Besides the maintenance of reduction result (primary endpoint), functional and subjective outcomes (secondary endpoints) were examined.</p> Methods/ Design <p>53 patients with isolated DRF were randomized to the orthosis group (OG) or the control group (CG). The follow-up examinations included radiological, clinical, and functional evaluations (ROM, grip strength, DASH score, SF-36) as well as patient satisfaction questionnaire. </p> Results <p>41 of the 53 patients included (OG: <i>n</i> = 21, CG: <i>n</i> = 20) were followed up until the 12 months follow-up. The rate of secondary dislocations was comparable in both groups (OG: <i>n</i> = 3; CG: <i>n</i> = 2; <i>p</i> &gt; 0.05). Additionally, the OG showed significantly (<i>p</i> &lt; 0.05) better subjective function (DASH score) 6 weeks and 3 months after injury, and a higher quality of life (SF-36 physical component summary) at 2 and 6 week follow-up. Patient satisfaction was significantly higher in OG and mean application time was significantly shorter (OG: 02:35 min vs. CG: 07:35 min; <i>p</i> &lt; 0.001).</p> Conclusion <p>This study’s functional and radiological results on conservative DRF treatment did not reveal a significant difference in maintenance of reduction result between modern orthoses and conventional plaster casts, while achieving higher patient satisfaction. Hence, orthoses offer a good alternative to plaster casts, especially for stable fracture types.</p> Trial registration <p>German Clinical Trials Register, Identifier: DRKS00017695. Trial registration date 04.11.2019, (<a href="https://drks.de/search/en/trial/DRKS00017695">https://drks.de/search/en/trial/DRKS00017695</a>)</p>