title: Clinical trial and in-vitro study comparing the efficacy of treating bony lesions with allografts versus synthetic or highly-processed xenogeneic bone grafts.
abstract: BACKGROUND
  Our study aim was to compare allogeneic cancellous bone (ACB) and synthetic or highly-processed xenogeneic bone substitutes (SBS) in the treatment of skeletal defects in orthopedic surgery.
  
  
  METHODS
  232 patients treated for bony lesions with ACB (n = 116) or SBS (n = 116) within a 10-year time period were included in this case-control study. Furthermore, both materials were seeded with human osteoblasts (hOB, n = 10) and analyzed by histology, for viability (AlamarBlue®) and protein expression activity (Luminex®).
  
  
  RESULTS
  The complication rate was 14.2 %, proportion of defects without bony healing 3.6 %; neither outcome parameter differed comparing the intervention groups. Failed consolidation correlated with an increase in complications (p < 0.03). The rate of complications was further highly significant in association with the location of use (p < 0.001), but did not depend on age, ASA risk classification, BMI, smoking behavior or type of insurance. However, those factors did significantly influence the bony healing rate (p < 0.02). Complication and consolidation rates were independent of gender and the filling substances employed within the different locations. Histological examination revealed similar bone structures, whereas cell remnants were apparent only in the allografts. Both materials were biocompatible in-vitro, and seeded with human osteoblasts. The cells remained vital over the 3-week culture period and produced microscopically typical bone matrix. We observed initially increased expression of osteocalcin, osteopontin, and osteoprotegerin as well as leptin and adiponectin secretion declining after 1 week, especially in the ACB group.
  
  
  CONCLUSIONS
  Although both investigated materials appeared to be similarly suitable for the treatment of skeletal lesions in-vivo and in-vitro, outcome was decisively influenced by other factors such as the site of use or epidemiological parameters.
authors.affiliation: Department of Orthopedics and Trauma Surgery, Albert-Ludwigs University Medical Center, Freiburg, Germany. johanna.kubosch@uniklinik-freiburg.de.
authors.forename: Eva Johanna
authors.initials: EJ
authors.lastname: Kubosch
authors.affiliation: Department of Orthopedics and Trauma Surgery, Albert-Ludwigs University Medical Center, Freiburg, Germany. anke.bernstein@uniklinik-freiburg.de.
authors.forename: Anke
authors.initials: A
authors.lastname: Bernstein
authors.affiliation: Department of Orthopedics and Trauma Surgery, Albert-Ludwigs University Medical Center, Freiburg, Germany. wolflaura@web.de.
authors.forename: Laura
authors.initials: L
authors.lastname: Wolf
authors.affiliation: Department of Craniomaxillofacial Surgery, Albert-Ludwigs University Medical Center, Freiburg, Germany. tobias.fretwurst@uniklinik-freiburg.de.
authors.forename: Tobias
authors.initials: T
authors.lastname: Fretwurst
authors.affiliation: Department of Craniomaxillofacial Surgery, Albert-Ludwigs University Medical Center, Freiburg, Germany. katja.nelson@uniklinik-freiburg.de.
authors.forename: Katja
authors.initials: K
authors.lastname: Nelson
authors.affiliation: Department of Orthopedics and Trauma Surgery, Albert-Ludwigs University Medical Center, Freiburg, Germany. hagen.schmal@freenet.de.|Department of Orthopaedics and Traumatology, Odense University Hospital, Odense, Denmark. hagen.schmal@freenet.de.|Department of Clinical Research, University of Southern Denmark, Odense, Denmark. hagen.schmal@freenet.de.
authors.forename: Hagen
authors.initials: H
authors.lastname: Schmal
mesh_terms: D000328:Adult; D000368:Aged; D064591:Allografts; D001847:Bone Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D018786:Bone Substitutes / Q000009:adverse effects / Q000627:therapeutic use*; D016025:Bone Transplantation / Q000009:adverse effects / Q000379:methods*; D016022:Case-Control Studies; D002470:Cell Survival; D002478:Cells, Cultured; D005260:Female; D064593:Heterografts; D006801:Humans; D008297:Male; D008875:Middle Aged; D016348:Osseointegration; D010006:Osteoblasts / Q000378:metabolism / Q000473:pathology; D011183:Postoperative Complications / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018786:Bone Substitutes