Cerament Treatment of Fracture Defects (CERTiFy)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01828905 |
Recruitment Status :
Completed
First Posted : April 11, 2013
Last Update Posted : March 4, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
AO 41-B2 and AO 41-B3 Tibia Fractures | Device: CERAMENT™|BONE VOID FILLER Procedure: Autologous cancellous bone graft | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 137 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | December 24, 2017 |
Actual Study Completion Date : | December 31, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Cerament
CERAMENT™|BONE VOID FILLER as bone graft substitute
|
Device: CERAMENT™|BONE VOID FILLER
ceramic bone void filler |
Active Comparator: Bone graft
Autologous cancellous bone graft (iliac crest)
|
Procedure: Autologous cancellous bone graft
autologous cancellous bone graft |
- SF-12 Physical Component Summary (PCS) at week 26 [ Time Frame: 26 weeks ]
- Global pain VAS score at week 26 [ Time Frame: 26 weeks ]
- Utilisation of costs of care related resources [ Time Frame: 26 weeks ]
- SF-12 PCS and MCS at visit 4 [ Time Frame: 1 week ]
- Bone healing [ Time Frame: 1, 6, 12 and 26 weeks ]Evaluated by X-ray
- SF-12 PCS and MCS at visit 5 [ Time Frame: 6 weeks ]
- SF-12 PCS and MCS at visit 6 [ Time Frame: 12 weeks ]
- SF-12 PCS and MCS at visit 7 [ Time Frame: 26 weeks ]
- Occurence of adverse events, device complaints and device-related incidents [ Time Frame: 26 weeks ]
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828905
Germany | |
Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar) | |
München, Bavaria, Germany, 81675 | |
Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg | |
Freiburg, Geogr. Baden-Wuerttemberg, Germany, 79106 | |
Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH | |
Bad Homburg, Hesse, Germany, 61348 | |
Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt | |
Frankfurt, Hesse, Germany, 60590 | |
Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda | |
Fulda, Hesse, Germany, 36043 | |
Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR) | |
Rüsselsheim, Hesse, Germany, 65428 | |
Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH | |
Aachen, Northrhine-Westfalia, Germany, 52074 | |
Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne | |
Cologne, Northrhine-Westfalia, Germany, 50937 | |
Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik) | |
Duisburg, Northrhine-Westfalia, Germany, 47249 | |
Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf | |
Düsseldorf, Northrhine-Westfalia, Germany, 40225 | |
Clinic of Trauma, Hand and Reconstructive Surgery | |
Münster, Northrhine-Westfalia, Germany, 48149 | |
Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein | |
Koblenz, Rhineland-Palatinate, Germany, 56068 | |
Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik) | |
Ludwigshafen, Rhineland-Palatinate, Germany, 67071 | |
Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms | |
Worms, Rhineland-Palatinate, Germany, 67550 | |
Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz | |
Mainz, Rhineland-Palatine, Germany, 55131 | |
Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck | |
Lübeck, Schleswig-Holstein, Germany, 23538 |
Principal Investigator: | Pol M. Rommens, Univ.-Prof., MD | Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz |
Responsible Party: | Univ.-Prof. Pol M. Rommens, Head of Department of Trauma Surgery, Director of the Center for Musculoskeletal Surgery, Johannes Gutenberg University Mainz |
ClinicalTrials.gov Identifier: | NCT01828905 |
Other Study ID Numbers: |
S041/2012 |
First Posted: | April 11, 2013 Key Record Dates |
Last Update Posted: | March 4, 2019 |
Last Verified: | March 2019 |
tibia fracture bone graft iliac crest bone graft substitute Cerament |
void filler quality of life pain costs of care |
Fractures, Bone Tibial Fractures Wounds and Injuries Leg Injuries |