Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT01828905
Status:
COMPLETED
Last Update Posted:
2019-03-04
First Post:
2013-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerament Treatment of Fracture Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-01', 'studyFirstSubmitDate': '2013-04-04', 'studyFirstSubmitQcDate': '2013-04-08', 'lastUpdatePostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Occurence of adverse events, device complaints and device-related incidents', 'timeFrame': '26 weeks', 'description': '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.\n\nNumber 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.'}], 'primaryOutcomes': [{'measure': 'SF-12 Physical Component Summary (PCS) at week 26', 'timeFrame': '26 weeks'}, {'measure': 'Global pain VAS score at week 26', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': 'Utilisation of costs of care related resources', 'timeFrame': '26 weeks'}, {'measure': 'SF-12 PCS and MCS at visit 4', 'timeFrame': '1 week'}, {'measure': 'Bone healing', 'timeFrame': '1, 6, 12 and 26 weeks', 'description': 'Evaluated by X-ray'}, {'measure': 'SF-12 PCS and MCS at visit 5', 'timeFrame': '6 weeks'}, {'measure': 'SF-12 PCS and MCS at visit 6', 'timeFrame': '12 weeks'}, {'measure': 'SF-12 PCS and MCS at visit 7', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tibia fracture', 'bone graft', 'iliac crest', 'bone graft substitute', 'Cerament', 'void filler', 'quality of life', 'pain', 'costs of care'], 'conditions': ['AO 41-B2 and AO 41-B3 Tibia Fractures']}, 'referencesModule': {'references': [{'pmid': '24606670', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with traumatic, closed, depression fracture of the proximal tibia (limited to AO type B2 \\& B3)\n* solitary trauma\n* candidate for bone grafting\n* patients between the age of 18 and 65 years\n* written informed consent obtained before any study-related activities\n* patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program\n\nExclusion Criteria:\n\n* patients with multiple injuries\n* polytrauma patients\n* compartment syndrome\n* previous iliac crest bone graft harvesting\n* local infection at the site of implantation\n* chronic pain disease\n* malignancy\n* rheumatoid arthritis\n* chronic cortisone intake\n* X-ray diagnostics not available, fracture cannot be classified\n* clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation\n* a pre-existing calcium metabolism disorder (e.g. hypercalcemia)\n* known hyperthyroidism or autonomous thyroid adenoma\n* history of serious reaction to iodine based radio contrast agents\n* women who are pregnant or breastfeeding\n* irreversible coagulopathy or bleeding disorder\n* history of physical or psychological condition that contraindicates the use of an investigational device or render the patient at high risk from treatment complications\n* history of hypersensitivity to the investigational device or any of its ingredients\n* participation in other clinical trials during the present clinical trial or within the last 1 month'}, 'identificationModule': {'nctId': 'NCT01828905', 'acronym': 'CERTiFy', 'briefTitle': 'Cerament Treatment of Fracture Defects', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures', 'orgStudyIdInfo': {'id': 'S041/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cerament', 'description': 'CERAMENT™\\|BONE VOID FILLER as bone graft substitute', 'interventionNames': ['Device: CERAMENT™|BONE VOID FILLER']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bone graft', 'description': 'Autologous cancellous bone graft (iliac crest)', 'interventionNames': ['Procedure: Autologous cancellous bone graft']}], 'interventions': [{'name': 'CERAMENT™|BONE VOID FILLER', 'type': 'DEVICE', 'description': 'ceramic bone void filler', 'armGroupLabels': ['Cerament']}, {'name': 'Autologous cancellous bone graft', 'type': 'PROCEDURE', 'description': 'autologous cancellous bone graft', 'armGroupLabels': ['Bone graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar)', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Geogr. Baden-Wuerttemberg', 'country': 'Germany', 'facility': 'Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '61348', 'city': 'Bad Homburg', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH', 'geoPoint': {'lat': 50.22683, 'lon': 8.61816}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '36043', 'city': 'Fulda', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'zip': '65428', 'city': 'Rüsselsheim am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR)', 'geoPoint': {'lat': 49.98955, 'lon': 8.42251}}, {'zip': '52074', 'city': 'Aachen', 'state': 'Northrhine-Westfalia', 'country': 'Germany', 'facility': 'Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '50937', 'city': 'Cologne', 'state': 'Northrhine-Westfalia', 'country': 'Germany', 'facility': 'Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '47249', 'city': 'Duisburg', 'state': 'Northrhine-Westfalia', 'country': 'Germany', 'facility': 'Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '40225', 'city': 'Düsseldorf', 'state': 'Northrhine-Westfalia', 'country': 'Germany', 'facility': 'Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '48149', 'city': 'Münster', 'state': 'Northrhine-Westfalia', 'country': 'Germany', 'facility': 'Clinic of Trauma, Hand and Reconstructive Surgery', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '56068', 'city': 'Koblenz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'zip': '67071', 'city': 'Ludwigshafen am Rhein', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)', 'geoPoint': {'lat': 49.48121, 'lon': 8.44641}}, {'zip': '67550', 'city': 'Worms', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms', 'geoPoint': {'lat': 49.63278, 'lon': 8.35916}}, {'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatine', 'country': 'Germany', 'facility': 'Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Pol M. Rommens, Univ.-Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Trauma Surgery, Director of the Center for Musculoskeletal Surgery', 'investigatorFullName': 'Univ.-Prof. Pol M. Rommens', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}