Comparing the clinical outcomes of an innovative bi-frame external fixation device compared to those of volar locking plate and external fixator device among patients with unstable distal radius fractures: a two-year retrospective comparative cohort study.

Background: Volar locking plate (VLP) fixation for unstable distal radius fractures (DRF) requires extensive soft tissue dissection and is associated with implant-related complications. Conventional external fixator (EF) carries risks such as reduction loss, pin loosening, and unstable traction. This study retrospectively evaluates the clinical efficacy and safety of a novel bi-frame external fixation device (BEF) compared with VLP and EF over a two-year period.

Methods: rA total of 131 patients with unstable DRF treated between 2015 and 2022 at the First Affiliated Hospital of Zhejiang Chinese Medical University were included (42 BEF, 44 EF, 45 VLP). Functional outcomes included wrist range of motion and grip strength. Patient-reported outcomes were assessed using the Visual Analog Scale (VAS), Patient-Rated Wrist Evaluation (PRWE), and Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scores. Radiographic parameters and complications were recorded. Statistical comparisons used t-tests, Mann-Whitney U-tests, and chi-square or Fisher's exact tests.

Results: Baseline characteristics were comparable. BEF showed significantly shorter time from injury to surgery than VLP (17.2±5.2 vs. 68.3±24.1 hours, p < 0.001), and shorter operation time than EF (p = 0.028) and VLP (p < 0.001). Early outcomes favored VLP, but long-term results were comparable (p > 0.05). Compared with EF, BEF better preserved radial height, ulnar variance, pronation, and ulnar deviation (all p < 0.05), with fewer overall complications (p = 0.005).

Conclusions: BEF represents an innovative, viable and safe alternative for unstable DRF. Further multicenter randomized trials with extended follow-up are warranted.