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Objectives and questions: Low-profile double-plating has been introduced as an alternative to single-plate osteosynthesis of midshaft clavicle fractures, aiming to reduce implant-related irritation and thereby the need for re-interventions. A multicentre prospective natural experiment was initiated to compare both techniques in clinical practice. This is a preliminary analysis of outcomes available after three years of enrolment and follow-up.

Material and methods: Adult patients undergoing operative fixation of midshaft clavicle fractures at the study centres were treated with either conventional superior single plating or low-profile double-plating constructs, according to each centre’s standard of care. Consequently, the geographical location of the accident served as the allocation mechanism. The primary outcome was reoperation within two years. Secondary outcomes included implant-related irritation, implant failures, operative time, and patient-reported function.

Results: By January 2026, 74 patients had completed 2-year, and 134 patients 1-year follow-up. Re-operations within two years were significantly lower in the double-plating group compared to single-plating (25.0% vs 59.5%, p = 0.006). This was mainly attributable to implant-related irritation, which was consistently more frequent in single-plating and increased over time, reaching 69% at final follow-up compared to 34% in double-plating. Implant failures were equally rare in both groups (5.3% double vs 4.3% single plating after 1 year, p = 0.99); notably, only 2 needed revision-osteosynthesis. Operative time was significantly shorter for double-plating (68 vs 86 min median, p < 0.001). At 12 weeks, single plating was associated with lower disability scores (9.1 vs 15.9 median, p = 0.016), although this difference attenuated in subgroup analysis excluding patients with concomitant injuries. Functional outcomes showed no significant nor clinically meaningful differences at one year (QuickDASH 2.3 vs 4.5 median, p = 0.36). No mal/non-unions were observed after 12 months, and no refractures after implant removal were reported to date.

Discussion and conclusions: This preliminary analysis suggests that low-profile double-plating is associated with substantially lower re-operation and implant irritation rates compared to single plating, without an increased risk of failure and with similar mid-term functional outcomes. Continued follow-up is warranted to confirm these findings at study completion.