Abstract
BackgroundBone 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/DesignCERTiFy (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.DiscussionCERTiFy 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 numberClinicalTrials.gov: NCT01828905
Highlights
Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects
The aim of this study is to compare the impact of CERAMENTTM BONE VOID FILLER (CBVF) and autologous bone graft on quality of life (QoL), pain, and costs of care in a standardized tibial plateau fracture (AO-Types 41-B2 and Arbeitsgemeinschaft Osteosynthese (AO) 41-B3 (Figure 1)) that are associated with a significant bone defect
The clinical and functional outcome when comparing the use of autologous bone graft with the use of a bone graft substitute has been investigated in several studies [8,13,22,27]
Summary
Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. Some well-recognized complications associated with graft harvesting including pain at the donor site, nerve injury, hematoma, infection and pelvic fracture at the donor site [6,7,8] may significantly influence the quality of life (QoL) of those patients [9]. Both prolonged operation time and hospital stay after bone graft harvesting may unnecessarily complicate the surgical treatment [9,10]
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