Clinical, patient-reported, and radiographic outcomes of proximal humerus open reduction internal fixation augmented with calcium sulfate hydroxyapatite bio-composite (CERAMENT BONE VOID FILLER)

Abstract

Introduction

To minimize the complications associated with proximal humerus open reduction internal fixation (ORIF), various augmentation strategies have been utilized to manage humeral head bone loss. The purpose of the study is to report clinical and patient reported outcomes of calcium sulfate hydroxyapatite bio-composite bone void filler augmentation of proximal humerus ORIF.

Methods

A prospective cohort of patients who sustained a proximal humerus fracture (PHF) treated with ORIF were collected between 2022–2024. All patients were treated with adjunctive calcium sulfate hydroxyapatite bio-composite bone void filler (CERAMENT BONE VOID FILLER, BONESUPPORT INC, Needham, MA) after reduction and instrumentation. Peri-operative complications were recorded. PROMIS scores of physical function and pain interference were collected. Follow-up radiographs were evaluated for bone void filler resorption/remodeling and union. These patients were 1:1 propensity matched to a retrospective comparative cohort of PHF without augmentation for comparative analysis.

Results

24 patients were enrolled in the study. 20 patients (83 %) were female. Mean age was 68±11 years and mean BMI was 29±7 kg/m². Patients had a mean follow up of 424±123 days. All patients had radiographic evidence of bone void filler resorption and remodeling at an average of 130±77 days. Of the 24 patients, 21 had available PROMIS scores. At final follow up, patients reported an average 46.3 ± 9.9 physical function score and 63.8 ± 6.3 pain interference score at an average of 273±191 days post operative. The 24 patients augmented with CBVF were matched to 24 patients with PHF without augmentation. Twenty-two patients in the CBVF group had fracture union compared to twenty in the non-augmented group(92 % vs 83 %, p = 0.38). Additionally, the CBVF group had reduced rates of screw penetration(4 % vs 21 %, p = 0.08), progressive fracture displacement(4 % vs 17 %, p = 0.16), and revision surgery(4 % vs 17 %, p = 0.16). On multivariate analysis, the use of CBVF significantly lowered the odds of developing intra-articular screw penetration(OR = 0.007, p = 0.02)

Conclusion

This series demonstrates favorable outcomes in proximal humerus ORIF augmented using calcium sulfate hydroxyapatite bio-composite as bone void filler compared to a matched cohort of patients treated without augmentation. There is a low rate of loss of fracture fixation and high union rate with favorable patient reported outcome measures.