title: Clinical use and safety of a novel gentamicin-releasing resorbable bone graft substitute in the treatment of osteomyelitis/osteitis.
abstract: OBJECTIVE
  A clinical investigation into a new bone void filler is giving first data on systemic and local exposure to the anti-infective substance after implantation.
  
  
  METHODS
  A total of 20 patients with post-traumatic/post-operative bone infections were enrolled in this open-label, prospective study. After radical surgical debridement, the bone cavity was filled with this material. The 21-day hospitalisation phase included determination of gentamicin concentrations in plasma, urine and wound exudate, assessment of wound healing, infection parameters, implant resorption, laboratory parameters, and adverse event monitoring. The follow-up period was six months.
  
  
  RESULTS
  Systemic exposure to gentamicin after implantation was very low as local gentamicin concentrations were measured in wound exudate after six to ten hours. There were no signs of infectious complication throughout the clinical phase. Four patients had recurrent infections several weeks to months after implantation. The outcome was deemed successful by remission of infection in 16 (80%) of these problematic long-term treated patients. Safety laboratory measurements did not indicate nephrotoxic or hepatotoxic effects.
  
  
  CONCLUSIONS
  Local application of calcium sulphate/carbonate bone void filler comprising gentamicin revealed sufficient active local levels of the antibiotic by simultaneous significant low systemic exposure in patients with mostly chronic osteomyelitis/osteitis. The material was safe and well tolerated. Cite this article: Bone Joint Res 2014;3:223-9.
authors.affiliation: Berufsgenossenschaftliche Unfallklinik, Friedberger Landstraße 430, 60389, Frankfurt, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Fleiter
authors.affiliation: Berufsgenossenschaftliche Unfallklinik, Friedberger Landstraße 430, 60389, Frankfurt, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Walter
authors.affiliation: Heraeus Medical, Philipp-Reiss-Strasse 8/13, 61273 Wehrheim, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Bösebeck
authors.affiliation: Heraeus Medical, Philipp-Reiss-Strasse 8/13, 61273 Wehrheim, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Vogt
authors.affiliation: Heraeus Medical, Philipp-Reiss-Strasse 8/13, 61273 Wehrheim, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Büchner
authors.affiliation: Facharztpraxis Chirurgie-Maintaunus, Dr. Enderle, Hirschberger & Partner, Waldstraße 9, 65812 Bad Soden, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Hirschberger
authors.affiliation: Berufsgenossenschaftliche Unfallklinik, Friedberger Landstraße 430, 60389, Frankfurt, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Hoffmann
keywords: Calcium sulfate; Gentamicin; Local antibiotic therapy; Osteomyelitis; Resorbable bone void filler