title: CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures.
abstract: BACKGROUND
  Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical study investigates the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement (CERAMENT™|BONE VOID FILLER (CBVF)).
  
  
  METHODS
  CERTiFy (CERament™ Treatment of Fracture defects) is a prospective, multicenter, controlled, randomized trial. We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia (types AO 41-B2 and AO 41-B3) in 13 participating centers in Germany. Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface. The primary outcome is the SF-12 Physical Component Summary at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints. The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life. The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group.
  
  
  CONCLUSIONS
  CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life, pain, and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures. The results are expected to influence future treatment recommendations.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01828905.
authors.forename: Thomas
authors.initials: T
authors.lastname: Nusselt
authors.affiliation: BiomaTiCS Group, Center for Orthopedics and Trauma Surgery, University Medical Center, Langenbeckstr, 1, Mainz D-55131, Germany. hofmann.trauma-surgery@gmx.net.
authors.forename: Alexander
authors.initials: A
authors.lastname: Hofmann
authors.forename: Daniel
authors.initials: D
authors.lastname: Wachtlin
authors.forename: Stanislav
authors.initials: S
authors.lastname: Gorbulev
authors.forename: Pol Maria
authors.initials: PM
authors.lastname: Rommens
mesh_terms: D018786:Bone Substitutes / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D016025:Bone Transplantation / Q000009:adverse effects / Q000191:economics; D002133:Calcium Sulfate / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004338:Drug Combinations; D017886:Durapatite / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D017102:Fracture Healing / Q000187:drug effects*; D005858:Germany; D017048:Health Care Costs; D006801:Humans; D007085:Ilium / Q000637:transplantation*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013978:Tibial Fractures / Q000000981:diagnostic imaging / Q000191:economics / Q000601:surgery / Q000628:therapy*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D018786:Bone Substitutes; D004338:Drug Combinations; C582328:cerament; D017886:Durapatite; D002133:Calcium Sulfate