The aim of the study is to compare fracture healing, quality of life, pain, and cost of care of the use of CERAMENT™\|BONE VOID FILLER as bone graft substitute to the use of autologous cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures treated by internal fixation and void reconstruction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
ceramic bone void filler
autologous cancellous bone graft
Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar)
München, Bavaria, Germany
SF-12 Physical Component Summary (PCS) at week 26
Time frame: 26 weeks
Global pain VAS score at week 26
Time frame: 26 weeks
Utilisation of costs of care related resources
Time frame: 26 weeks
SF-12 PCS and MCS at visit 4
Time frame: 1 week
Bone healing
Evaluated by X-ray
Time frame: 1, 6, 12 and 26 weeks
SF-12 PCS and MCS at visit 5
Time frame: 6 weeks
SF-12 PCS and MCS at visit 6
Time frame: 12 weeks
SF-12 PCS and MCS at visit 7
Time frame: 26 weeks
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Freiburg im Breisgau, Geogr. Baden-Wuerttemberg, Germany
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Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt
Frankfurt am Main, Hesse, Germany
Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda
Fulda, Hesse, Germany
Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR)
Rüsselsheim am Main, Hesse, Germany
Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH
Aachen, Northrhine-Westfalia, Germany
Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne
Cologne, Northrhine-Westfalia, Germany
Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
Duisburg, Northrhine-Westfalia, Germany
Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf
Düsseldorf, Northrhine-Westfalia, Germany
...and 6 more locations