title: Augmentation of tibial plateau fractures with an injectable bone substitute: CERAMENT™. Three year follow-up from a prospective study.
abstract: BACKGROUND
  Reduction of tibial plateau fractures and maintain a level of well aligned congruent joint is key to a satisfactory clinical outcome and is important for the return to pre-trauma level of activity. Stable internal fixation support early mobility and weight bearing. The augmentation with bone graft substitute is often required to support the fixation to mantain reduction. For these reasons there has been development of novel bone graft substitutes for trauma applications and in particular synthetic materials based on calcium phosphates and/or apatite combined with calcium sulfates. Injectable bone substitutes can optimize the filling of irregular bone defects. The purpose of this study was to assess the potential of a novel injectable bone substitute CERAMENT™|BONE VOID FILLER in supporting the initial reduction and preserving alignment of the joint surface until fracture healing.
  
  
  METHODS
  From June 2010 through May 2011 adult patients presenting with acute, closed and unstable tibial plateau fractures which required both grafting and internal fixation, were included in a prospective study with percutaneous or open reduction and internal fixation (ORIF) augmented with an injectable ceramic biphasic bone substitute CERAMENT™|BONE VOID FILLER (BONESUPPORT™, Lund, Sweden) to fill residual voids. Clinical follow up was performed at 1, 3, 9 and 12 months and any subsequent year; including radiographic analysis and Rasmussen system for knee functional grading.
  
  
  RESULTS
  Twenty four patients, balanced male-to-female, with a mean age of 47 years, were included and followed with an average of 44 months (range 41-52 months). Both Schatzker and Müller classifications were used and was type II or 41-B3 in 7 patients, type III or 41-B2 in 12 patients, type IV or 41-C1 in 2 patients and type VI or 41-C3 in 3 patients, respectively. The joint alignement was satisfactory and manteined within a range of 2 mm, with an average of 1.18 mm. The mean Rasmussen knee function score was 26.5, with 14 patients having an excellent result and the remaining 10 with a good result.
  
  
  CONCLUSIONS
  It can be concluded that radiological and clinical outcome was satisfactory and obtained in all cases without complications. This injectable novel biphasic hydroxyapatite and calcium sulfate ceramic material is a valuable armamentarium in the treatment of trauma where bone graft is required.
authors.affiliation: Department of Orthopedics and Traumatology, University "Tor Vergata", "Policlinico Tor Vergata" Foundation, Viale Oxford 81, 00133, Rome, Italy. riccardo.iundusi@uniroma2.it.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Iundusi
authors.affiliation: Department of Orthopedics and Traumatology, University "Tor Vergata", "Policlinico Tor Vergata" Foundation, Viale Oxford 81, 00133, Rome, Italy. elenagasbarra@tiscali.it.
authors.forename: Elena
authors.initials: E
authors.lastname: Gasbarra
authors.affiliation: Orthopaedic Department, University of Palermo, Via del Vespro, 90100, Palermo, Italy. mdarienzo@unipa.it.
authors.forename: Michele
authors.initials: M
authors.lastname: D'Arienzo
authors.affiliation: Oncologic Center, "Palazzo Baleani", Azienda Policlinico Umberto I, Corso Vittorio Emanuele II 244, Rome, Italy. piccioli.and@gmail.com.
authors.forename: Andrea
authors.initials: A
authors.lastname: Piccioli
authors.affiliation: Department of Orthopedics and Traumatology, University "Tor Vergata", "Policlinico Tor Vergata" Foundation, Viale Oxford 81, 00133, Rome, Italy. umberto.tarantino@uniroma2.it.
authors.forename: Umberto
authors.initials: U
authors.lastname: Tarantino
mesh_terms: D000328:Adult; D001696:Biomechanical Phenomena; D018786:Bone Substitutes / Q000008:administration & dosage*; D016025:Bone Transplantation; D002133:Calcium Sulfate / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D004338:Drug Combinations; D017886:Durapatite / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005593:Fracture Fixation, Internal; D017102:Fracture Healing / Q000187:drug effects*; D006801:Humans; D007267:Injections; D007719:Knee Joint / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020127:Recovery of Function; D013977:Tibia / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology / Q000601:surgery; D013978:Tibial Fractures / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D018786:Bone Substitutes; D004338:Drug Combinations; C582328:cerament; D017886:Durapatite; D002133:Calcium Sulfate