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CERAMENT treatment of fracture defects (CERTiFy): a prospective, multicenter, randomized study

Laufzeit: 01.01.2013 - 31.12.2016

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Kurzfassung


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...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)).
136 patients are being randomized in 19 participating centers in Germany (Department of Orthopedics and Traumatology Mainz as principle investigator center).
Trial registration number: ClinicalTrials.gov: NCT01828905
Sponsor: BoneSupport GmbH
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