Outcome analysis of conservative treatment of a distal radius fracture with OPTIVOhand orthosis versus plaster cast: a randomized controlled trial

BACKGROUND: ) with plaster cast immobilization. Besides the maintenance of reduction result (primary endpoint), functional and subjective outcomes (secondary endpoints) were examined. METHODS/ DESIGN: 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. RESULTS: 41 of the 53 patients included (OG: n = 21, CG: n = 20) were followed up until the 12 months follow-up. The rate of secondary dislocations was comparable in both groups (OG: n = 3; CG: n = 2; p > 0.05). Additionally, the OG showed significantly (p < 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; p < 0.001). CONCLUSION: 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. TRIAL REGISTRATION: German Clinical Trials Register, Identifier: DRKS00017695. Trial registration date 04.11.2019, ( https://drks.de/search/en/trial/DRKS00017695 ).