Status:
COMPLETED
Cerament Treatment of Fracture Defects
Lead Sponsor:
Johannes Gutenberg University Mainz
Conditions:
AO 41-B2 and AO 41-B3 Tibia Fractures
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- patients with traumatic, closed, depression fracture of the proximal tibia (limited to AO type B2 \& B3)
- solitary trauma
- candidate for bone grafting
- patients between the age of 18 and 65 years
- written informed consent obtained before any study-related activities
- patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program
Exclusion
- patients with multiple injuries
- polytrauma patients
- compartment syndrome
- previous iliac crest bone graft harvesting
- local infection at the site of implantation
- chronic pain disease
- malignancy
- rheumatoid arthritis
- chronic cortisone intake
- X-ray diagnostics not available, fracture cannot be classified
- clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
- a pre-existing calcium metabolism disorder (e.g. hypercalcemia)
- known hyperthyroidism or autonomous thyroid adenoma
- history of serious reaction to iodine based radio contrast agents
- women who are pregnant or breastfeeding
- irreversible coagulopathy or bleeding disorder
- history of physical or psychological condition that contraindicates the use of an investigational device or render the patient at high risk from treatment complications
- history of hypersensitivity to the investigational device or any of its ingredients
- participation in other clinical trials during the present clinical trial or within the last 1 month
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01828905
Start Date
April 1 2013
End Date
December 31 2018
Last Update
March 4 2019
Active Locations (16)
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1
Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar)
München, Bavaria, Germany, 81675
2
Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg
Freiburg im Breisgau, Geogr. Baden-Wuerttemberg, Germany, 79106
3
Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH
Bad Homburg, Hesse, Germany, 61348
4
Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt
Frankfurt am Main, Hesse, Germany, 60590