Clinical trial NCT01828905: Cerament Treatment of Fracture Defects
Official title: A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AO 41-B2 and AO 41-B3 Tibia Fractures
Keywords: tibia fracture
bone graft
iliac crest
bone graft substitute
Cerament
void filler
quality of life
pain
costs of care
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: SF-12 Physical Component Summary (PCS) at week 26
timeFrame: 26 weeks
measure: Global pain VAS score at week 26
timeFrame: 26 weeks
Secondary outcomes:
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
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
Other outcomes:
measure: Occurence of adverse events, device complaints and device-related incidents
timeFrame: 26 weeks
Locations:
city: München
country: Germany
facility: Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar)
state: Bavaria
city: Freiburg
country: Germany
facility: Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg
state: Geogr. Baden-Wuerttemberg
city: Bad Homburg
country: Germany
facility: Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH
state: Hesse
city: Frankfurt
country: Germany
facility: Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt
state: Hesse
city: Fulda
country: Germany
facility: Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda
state: Hesse
city: Rüsselsheim
country: Germany
facility: Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR)
state: Hesse
city: Aachen
country: Germany
facility: Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH
state: Northrhine-Westfalia
city: Cologne
country: Germany
facility: Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne
state: Northrhine-Westfalia
city: Duisburg
country: Germany
facility: Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
state: Northrhine-Westfalia
city: Düsseldorf
country: Germany
facility: Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf
state: Northrhine-Westfalia
city: Münster
country: Germany
facility: Clinic of Trauma, Hand and Reconstructive Surgery
state: Northrhine-Westfalia
city: Koblenz
country: Germany
facility: Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein
state: Rhineland-Palatinate
city: Ludwigshafen
country: Germany
facility: Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
state: Rhineland-Palatinate
city: Worms
country: Germany
facility: Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms
state: Rhineland-Palatinate
city: Mainz
country: Germany
facility: Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
state: Rhineland-Palatine
city: Lübeck
country: Germany
facility: Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck
state: Schleswig-Holstein
Study officials:
affiliation: Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
name: Pol M. Rommens, Univ.-Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
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.