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Clinical and Radiographic Outcomes of Locking-Plate Fixation Augmented with a Porous Hydroxyapatite Bone Substitute
Achille Saracco1, Leo Massari1, Marco Amadio2
1Department of Translational Medicine and for Romagna, University of Ferrara, c/o "S. Anna", Via Aldo Moro 8, 44124 Ferrara, Italy.
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 comparative cohort study including 45 patients treated with locking-plate fixation and porous hydroxyapatite scaffold augmentation and 40 comparable control patients treated with locking-plate fixation without scaffold augmentation. 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. Functional recovery and pain reduction followed a similar trajectory in both groups, with no significant group-by-time interaction.
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 retrospective, non-randomized design, limited sample size, potential selection bias, and incomplete follow-up in part of the cohort, these findings should be interpreted as supportive of feasibility and short- to mid-term safety rather than as definitive evidence of biomaterial efficacy.
Level Of Evidence:
Level III, retrospective cohort study.