AO 41-B2 and AO 41-B3 Tibia Fractures Clinical Trial
— CERTiFyOfficial title:
A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures
| NCT number | NCT01828905 |
| Other study ID # | S041/2012 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2013 |
| Est. completion date | December 31, 2018 |
| Verified date | March 2019 |
| Source | Johannes Gutenberg University Mainz |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 137 |
| Est. completion date | December 31, 2018 |
| Est. primary completion date | December 24, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH | Aachen | Northrhine-Westfalia |
| Germany | Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH | Bad Homburg | Hesse |
| 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, University Clinics of Frankfurt | Frankfurt | Hesse |
| Germany | Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg | Freiburg | Geogr. Baden-Wuerttemberg |
| Germany | Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda | Fulda | Hesse |
| Germany | Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein | Koblenz | Rhineland-Palatinate |
| Germany | Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck | Lübeck | Schleswig-Holstein |
| Germany | Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik) | Ludwigshafen | Rhineland-Palatinate |
| Germany | Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz | Mainz | Rhineland-Palatine |
| Germany | Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar) | München | Bavaria |
| Germany | Clinic of Trauma, Hand and Reconstructive Surgery | Münster | Northrhine-Westfalia |
| Germany | Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR) | Rüsselsheim | Hesse |
| Germany | Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms | Worms | Rhineland-Palatinate |
| Lead Sponsor | Collaborator |
|---|---|
| Johannes Gutenberg University Mainz |
Germany,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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. |
26 weeks | |
| Primary | SF-12 Physical Component Summary (PCS) at week 26 | 26 weeks | ||
| Primary | Global pain VAS score at week 26 | 26 weeks | ||
| Secondary | Utilisation of costs of care related resources | 26 weeks | ||
| Secondary | SF-12 PCS and MCS at visit 4 | 1 week | ||
| Secondary | Bone healing | Evaluated by X-ray | 1, 6, 12 and 26 weeks | |
| Secondary | SF-12 PCS and MCS at visit 5 | 6 weeks | ||
| Secondary | SF-12 PCS and MCS at visit 6 | 12 weeks | ||
| Secondary | SF-12 PCS and MCS at visit 7 | 26 weeks |