Calcium-Based, Antibiotic-Loaded Bone Substitute as an Implant Coating: A Pilot Clinical Study

Abstract. Background: Implant-related infections remain a major complication after orthopaedic surgery. Antibacterial coating of implants may prevent bacterial adhesion and biofilm formation. However, in spite of extensive preclinical research in the field, antibacterial coatings to protect orthopaedic implants in the clinical setting remain particularly few. The aim of the present study is to evaluate the safety of a calcium-based, antibiotic-loaded bone substitute as an antibacterial coating of cementless joint prosthesis.

Methods: From March 2013 to August 2015, 20 consecutive patients scheduled for cementless or hybrid two-stage revision surgery for peri-prosthetic joint infection were included in this prospective, observational, pilot study. Cerament G or Cerament V, a gentamicin or vancomycin-loaded calcium-based resorbable bone substitute (60% calcium sulphate, 40% hydroxyapatite), was applied at surgery on the stem surface of hip (n=7) or knee (n=13) revision prosthesis. After surgery, all patients underwent clinical (HHS or KSS and SF-12 score), laboratory and radiographic evaluation at 3, 6 and 12 months and yearly thereafter.

Results: At a minimum of 12 months follow-up, 19/20 (95%) patients showed no recurrence of infection and no signs of radiographic loosening of the stem. No adverse events were associated with the use of Cerament G or V.

Conclusions: This is the first pilot clinical study on the short-term safety of using a calcium-based, gentamicin or vancomycin-loaded bone substitute as a surface coating on cementless prosthetic implants. If confirmed by larger studies and at longer follow-ups, these findings may open a new prospective to protect intra-operatively orthopedic implants from bacterial adhesion, through the use of resorbable, osteoconductive, antibiotic carriers.