Submitted:
02 April 2026
Posted:
03 April 2026
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Abstract
Background: Evidence on the role of synthetic biomimetic bone substitutes in the surgical management of proximal humerus fractures remains limited. This study aimed to evaluate the clinical, radiographic, and safety outcomes of a porous hydroxyapatite bone substitute used as an adjunct to locking-plate fixation in proximal humerus fractures with metaphyseal bone loss. Methods: We performed a retrospective cohort study including 45 patients treated between January 2022 and January 2025 with open reduction and internal fixation using a locking plate and a preformed porous hydroxyapatite scaffold (ENGIpore SH). Patients were evaluated clinically and radiographically at 1, 3, 6, and 12 months after surgery. Functional outcome was assessed with the Constant-Murley Score (CMS), and pain was assessed using the Visual Analogue Scale (VAS). Longitudinal changes over time were analyzed using mixed-effects models for repeated measures. Results: CMS improved progressively over follow-up, whereas VAS pain scores decreased significantly over time. No cases of device migration or radiographic resorption were observed during follow-up. Adverse events were recorded, but no complication was considered directly attributable to the implanted biomaterial. Conclusions: In this retrospective series, graft augmentation with a porous hydroxyapatite scaffold during locking-plate fixation of proximal humerus fractures with bone void was associated with progressive functional improvement and pain reduction, without evident device-related safety concerns. Owing to the observational design and lack of a control group, these findings should be interpreted as supportive of feasibility and short- to mid-term safety rather than proof of biomaterial efficacy.
