Abstract

BackgroundThe primary objective was to investigate the clinical and radiological outcome in patients undergoing major hip surgery using a novel antibiotic containing bone substitute for local augmentation in trochanteric fracture fixation or revision of total hip arthroplasty (THA).MethodsWe implanted a novel biphasic bone substitute CERAMENT™|G consisting of hydroxyapatite, calcium sulphate and gentamicin for bone regeneration and local antibiotic delivery in 20 patients treated surgically for trochanteric femoral fracture or uncemented hip revision. Preoperative, postoperative, 3 months and 1 year clinical and radiological assessment were performed including registration of any complications. In one trochanteric fracture patient, histological analyses were performed of bone biopsies taken at removal of hardware.ResultsNone of the trochanteric fractures or revision of THA showed any large migration. No local wound disturbances were seen and no infection was observed at one year follow-up. All trochanteric fractures healed at 3 months with a minimal sliding screw displacement on average 3 mm. Radiological analysis showed signs of bone remodeling and new bone formation in the substitute, illustrated also by histology in the biopsies taken from one trochanteric fracture at one year post-op.ConclusionsLocal CERAMENT™|G was shown to be safe in a limited prospective major hip surgery study. Remodeling of the bone graft substitute was observed in all patients.Trial registrationEU-CTR2018–004414-18 Retrospectively registered on November 20, 2018.

Highlights

  • The primary objective was to investigate the clinical and radiological outcome in patients undergoing major hip surgery using a novel antibiotic containing bone substitute for local augmentation in trochanteric fracture fixation or revision of total hip arthroplasty (THA)

  • We investigated local elution of gentamicin in patients treated for trochanteric fractures or revision of total hip arthroplasty (THA) when CERAMENTTM|G was used for bone defect reconstruction [7]

  • The prospective study consisted of 20 patients (3 men, 17 women) with a mean age of 74.8 years, (±SD 9.5 years, range 57–90 years) who underwent either trochanteric fracture fixation using dynamic hip screw (DHS) or aseptic revision of THA using uncemented distal fixation modular stem (10 for each group) (Tables 1 and 2)

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Summary

Introduction

The primary objective was to investigate the clinical and radiological outcome in patients undergoing major hip surgery using a novel antibiotic containing bone substitute for local augmentation in trochanteric fracture fixation or revision of total hip arthroplasty (THA). Deep bone and joint infections after orthopaedic procedures are a devastating complication which may require revision surgery and longterm systemic antimicrobial treatment [1]. CERAMENTTM|G is an injectable biphasic bone substitute, composed of 60% calcium sulphate, which resorbs and provides gradual porosity for new bone ingrowth, supported by 40% hydroxyapatite that acts as matrix for bone cells. Animals treated with CERAMENTTM|G showed no evidence of infection and retained a higher bone mass compared to the contralateral (non-operated) side 6 months post-op

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