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

Trials

Pol Maria Rommens²  Stanislav Gorbulev¹  Daniel Wachtlin¹  Alexander Hofmann²  Thomas Nusselt² 

[1] Interdisziplinäres Zentrum Klinische Studien (IZKS), University Medical Center, Langenbeckstr. 1, Mainz D-55131, Germany;BiomaTiCS Group, Center for Orthopedics and Trauma Surgery, University Medical Center, Langenbeckstr. 1, Mainz D-55131, Germany

关键词: pain;    quality of life;    fracture;    bone void;    bone substitute;    bone graft;   

Others  :  807316
DOI  :  10.1186/1745-6215-15-75

 received in 2013-10-06, accepted in 2014-02-14,  发布年份 2014

【 摘 要 】

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/Design

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.

Discussion

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.

Trial registration number

ClinicalTrials.gov: NCT01828905

【 授权许可】

   
2014 Nusselt et al.; licensee BioMed Central Ltd.

【 图 表 】

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