Comparison of two-stage open reduction and internal fixation and single-stage external fixation for complex pilon...

To compare functional and radiological outcomes between two stage ORIF and single stage external fixation for complex pilon fractures.

Prospective, single-center randomized controlled trial at a Level I trauma facility (April 2021-April 2023). Sixty skeletally mature patients with AO/OTA 43-C pilon fractures unsuitable for primary ORIF were randomized to two-stage ORIF (control group) or single-stage limited internal fixation with external fixation (LIFEF) (treatment group). Minimum follow-up was 24 months. The primary outcome was the AOFAS score at final follow-up. Secondary outcomes included time to union, time to return to work, ankle range of motion (ROM), fracture-related infection (FRI), bone-healing complications (nonunion, malunion, delayed union), post-traumatic osteoarthritis (PTOA), and need for secondary procedures.

All 60 patients completed follow-up. Compared with LIFEF, two-stage ORIF achieved higher AOFAS scores (85 ± 9 vs. 77 ± 10; P = 0.006), earlier return to work (7 ± 1.5 vs. 10 ± 3 months; P < 0.001), and shorter time to union (17 ± 3.6 vs. 19 ± 3.5 weeks; P = 0.02). Groups did not differ in quality of reduction (P = 0.14), ankle ROM (P = 0.10 and 0.058 for dorsiflexion and plantarflexion), FRI (P = 0.69), PTOA (P = 0.64), or bone-healing complications (nonunion, delayed union, malunion; P = 0.24, 0.39, 0.39).

Two-stage ORIF provided superior functional outcomes and faster recovery (earlier union and return to work) compared with LIFEF, with similar reduction quality and complication rates. These findings support two-stage ORIF as the preferred strategy for AO/OTA 43-C pilon fractures with soft-tissue compromise.

ClinicalTrials.gov , NCT05141227, Registration date: 29 July 2021.