RESUMEN
BACKGROUND: Evidence on antibiotic-loaded bone cement remains too vague to guide kyphoplasty in patient care. We clinically evaluated the properties and benefits of a new low viscosity polymethylmethacrylate (PMMA) bone cement loaded with gentamicin. METHODS: In this non-randomised, monocentric, prospective open trial, 50 consecutively enrolled patients with fractures of the vertebral body (TH7-L4) due to osteoporosis or trauma were investigated between 2010 and 2013, with a 1-year post-op follow-up per patient. The antibiotic-loaded PMMA bone cement was administered to patients during the surgery according to the standard procedure established on site for one-staged kyphoplasty. The clinical outcome was assessed according to function and pain by standardised anamnesis, clinical investigation, validated visual analogue scale (VAS) vertebral spine score, Oswestry Low-Back-Pain (ODI) Disability score, and Short Form (SF)-36 score. We further performed X-ray and magnetic resonance imaging with radiomorphometric assessment. RESULTS: The patients showed beneficial effects concerning low back pain disability (mean ODI score; screening, 68.0 ± 15.8% vs month 12, 42.8 ± 24.5%). The pain level was decreased (VAS vertebral spine score; screening, 68.8 ± 17.6 vs month 12, 43.8 ± 22.2) and the general health state was improved (SF-36; especially 'role limitations due to emotional problems' (51.9 ± 44.7; month 6), followed by 'role limitations due to physical health' (36.1 ± 42.4; month 6), and 'pain' (34.6 ± 35.3; month 6)). No vertebral infection did occur during the hospital stay or the 1-year follow-up. The stabilisation and restoration of the fractured bodies were radiologically confirmed. A reduced rate of leakage was observed, combined with a decreased risk of infection and an improved patient safety after a 1-year follow-up period. CONCLUSION: Requirements for bone cement in a kyphoplasty setting were excellently fulfilled. Application technique and cement properties may influence the success of the surgery. TRIAL REGISTRATION: Deutsche Institut für Medizinische Dokumentation und Information (DIMDI), HM-KS-0901, Registered 14 September 2009, https://www.dimdi.de/dynamic/de/medizinprodukte/datenbankrecherche/.