Cerament Treatment of Fracture Defects
Launched by JOHANNES GUTENBERG UNIVERSITY MAINZ · Apr 8, 2013
Trial Information
Current as of May 28, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz, a leading research institution in Germany, is dedicated to advancing medical science through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university integrates cutting-edge research and education to address critical health challenges. Its commitment to ethical standards and scientific rigor ensures that clinical trials are conducted with the utmost integrity, aiming to translate research findings into effective therapies and improved patient outcomes. Through its robust infrastructure and expert faculty, Johannes Gutenberg University Mainz plays a pivotal role in enhancing the landscape of clinical research and contributing to global health advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
München, Bavaria, Germany
Freiburg, Geogr. Baden Wuerttemberg, Germany
Bad Homburg, Hesse, Germany
Frankfurt, Hesse, Germany
Fulda, Hesse, Germany
Rüsselsheim, Hesse, Germany
Aachen, Northrhine Westfalia, Germany
Cologne, Northrhine Westfalia, Germany
Duisburg, Northrhine Westfalia, Germany
Düsseldorf, Northrhine Westfalia, Germany
Münster, Northrhine Westfalia, Germany
Koblenz, Rhineland Palatinate, Germany
Ludwigshafen, Rhineland Palatinate, Germany
Worms, Rhineland Palatinate, Germany
Mainz, Rhineland Palatine, Germany
Lübeck, Schleswig Holstein, Germany
Patients applied
Trial Officials
Pol M. Rommens, Univ.-Prof., MD
Principal Investigator
Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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