Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
137 participants
INTERVENTIONAL
2013-04-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cerament
CERAMENT™\|BONE VOID FILLER as bone graft substitute
CERAMENT™|BONE VOID FILLER
ceramic bone void filler
Bone graft
Autologous cancellous bone graft (iliac crest)
Autologous cancellous bone graft
autologous cancellous bone graft
Interventions
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CERAMENT™|BONE VOID FILLER
ceramic bone void filler
Autologous cancellous bone graft
autologous cancellous bone graft
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Johannes Gutenberg University Mainz
OTHER
Responsible Party
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Univ.-Prof. Pol M. Rommens
Head of Department of Trauma Surgery, Director of the Center for Musculoskeletal Surgery
Principal Investigators
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Pol M. Rommens, Univ.-Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
Locations
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Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar)
München, Bavaria, Germany
Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg
Freiburg im Breisgau, Geogr. Baden-Wuerttemberg, Germany
Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH
Bad Homburg, Hesse, Germany
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
Clinic of Trauma, Hand and Reconstructive Surgery
Münster, Northrhine-Westfalia, Germany
Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein
Koblenz, Rhineland-Palatinate, Germany
Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms
Worms, Rhineland-Palatinate, Germany
Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatine, Germany
Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck
Lübeck, Schleswig-Holstein, Germany
Countries
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References
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Nusselt T, Hofmann A, Wachtlin D, Gorbulev S, Rommens PM. 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. 2014 Mar 8;15:75. doi: 10.1186/1745-6215-15-75.
Other Identifiers
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S041/2012
Identifier Type: -
Identifier Source: org_study_id
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