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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerament | Experimental | CERAMENT™|BONE VOID FILLER as bone graft substitute |
|
| Bone graft | Active Comparator | Autologous cancellous bone graft (iliac crest) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CERAMENT™|BONE VOID FILLER | Device | ceramic bone void filler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SF-12 Physical Component Summary (PCS) at week 26 | 26 weeks | |
| Global pain VAS score at week 26 | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Utilisation of costs of care related resources | 26 weeks | |
| SF-12 PCS and MCS at visit 4 | 1 week | |
| Bone healing |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of adverse events, device complaints and device-related incidents | Frequencies of subjects experiencing at least one adverse event (AE) will be displayed by body system and preferred term according to MedDRA terminology. Detailed information collected for each AE will include: a description of the event, duration, whether the AE was serious, intensity, relationship to trial device, action taken, clinical outcome. Summary tables will present the number of subjects observed with AEs and corresponding percentages. Number of device complaints and device-related incidents (AE related to the trial device) respectively as well as the frequencies of occurences of these events in both groups will be calculated. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pol M. Rommens, Univ.-Prof., MD | Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar) | München | Bavaria | 81675 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24606670 | Background | 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. |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| D010146 | Pain |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D009461 | Neurologic Manifestations |
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| Autologous cancellous bone graft |
| Procedure |
autologous cancellous bone graft |
|
Evaluated by X-ray |
| 1, 6, 12 and 26 weeks |
| SF-12 PCS and MCS at visit 5 | 6 weeks |
| SF-12 PCS and MCS at visit 6 | 12 weeks |
| SF-12 PCS and MCS at visit 7 | 26 weeks |
| 26 weeks |
| Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg |
| Freiburg im Breisgau |
| Geogr. Baden-Wuerttemberg |
| 79106 |
| Germany |
| Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH | Bad Homburg | Hesse | 61348 | Germany |
| Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda | Fulda | Hesse | 36043 | Germany |
| Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR) | Rüsselsheim am Main | Hesse | 65428 | Germany |
| Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH | Aachen | Northrhine-Westfalia | 52074 | Germany |
| Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne | Cologne | Northrhine-Westfalia | 50937 | Germany |
| Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik) | Duisburg | Northrhine-Westfalia | 47249 | Germany |
| Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf | Düsseldorf | Northrhine-Westfalia | 40225 | Germany |
| Clinic of Trauma, Hand and Reconstructive Surgery | Münster | Northrhine-Westfalia | 48149 | Germany |
| Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein | Koblenz | Rhineland-Palatinate | 56068 | Germany |
| Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik) | Ludwigshafen am Rhein | Rhineland-Palatinate | 67071 | Germany |
| Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms | Worms | Rhineland-Palatinate | 67550 | Germany |
| Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz | Mainz | Rhineland-Palatine | 55131 | Germany |
| Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck | Lübeck | Schleswig-Holstein | 23538 | Germany |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |