Cerament Treatment of Fracture Defects (CERTiFy)
Primary Purpose
AO 41-B2 and AO 41-B3 Tibia Fractures
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CERAMENT™|BONE VOID FILLER
Autologous cancellous bone graft
Sponsored by
About this trial
This is an interventional treatment trial for AO 41-B2 and AO 41-B3 Tibia Fractures focused on measuring tibia fracture, bone graft, iliac crest, bone graft substitute, Cerament, void filler, quality of life, pain, costs of care
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
Sites / Locations
- Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar)
- Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg
- Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH
- Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt
- Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda
- Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR)
- Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH
- Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne
- Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
- Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf
- Clinic of Trauma, Hand and Reconstructive Surgery
- Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein
- Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
- Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms
- Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
- Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cerament
Bone graft
Arm Description
CERAMENT™|BONE VOID FILLER as bone graft substitute
Autologous cancellous bone graft (iliac crest)
Outcomes
Primary Outcome Measures
SF-12 Physical Component Summary (PCS) at week 26
Global pain VAS score at week 26
Secondary Outcome Measures
Utilisation of costs of care related resources
SF-12 PCS and MCS at visit 4
Bone healing
Evaluated by X-ray
SF-12 PCS and MCS at visit 5
SF-12 PCS and MCS at visit 6
SF-12 PCS and MCS at visit 7
Full Information
NCT ID
NCT01828905
First Posted
April 4, 2013
Last Updated
March 1, 2019
Sponsor
Johannes Gutenberg University Mainz
1. Study Identification
Unique Protocol Identification Number
NCT01828905
Brief Title
Cerament Treatment of Fracture Defects
Acronym
CERTiFy
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 24, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cerament
Arm Type
Experimental
Arm Description
CERAMENT™|BONE VOID FILLER as bone graft substitute
Arm Title
Bone graft
Arm Type
Active Comparator
Arm Description
Autologous cancellous bone graft (iliac crest)
Intervention Type
Device
Intervention Name(s)
CERAMENT™|BONE VOID FILLER
Intervention Description
ceramic bone void filler
Intervention Type
Procedure
Intervention Name(s)
Autologous cancellous bone graft
Intervention Description
autologous cancellous bone graft
Primary Outcome Measure Information:
Title
SF-12 Physical Component Summary (PCS) at week 26
Time Frame
26 weeks
Title
Global pain VAS score at week 26
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Utilisation of costs of care related resources
Time Frame
26 weeks
Title
SF-12 PCS and MCS at visit 4
Time Frame
1 week
Title
Bone healing
Description
Evaluated by X-ray
Time Frame
1, 6, 12 and 26 weeks
Title
SF-12 PCS and MCS at visit 5
Time Frame
6 weeks
Title
SF-12 PCS and MCS at visit 6
Time Frame
12 weeks
Title
SF-12 PCS and MCS at visit 7
Time Frame
26 weeks
Other Pre-specified Outcome Measures:
Title
Occurence of adverse events, device complaints and device-related incidents
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.
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.
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pol M. Rommens, Univ.-Prof., MD
Organizational Affiliation
Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar)
City
München
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Facility Name
Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg
City
Freiburg
State/Province
Geogr. Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH
City
Bad Homburg
State/Province
Hesse
ZIP/Postal Code
61348
Country
Germany
Facility Name
Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt
City
Frankfurt
State/Province
Hesse
ZIP/Postal Code
60590
Country
Germany
Facility Name
Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda
City
Fulda
State/Province
Hesse
ZIP/Postal Code
36043
Country
Germany
Facility Name
Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR)
City
Rüsselsheim
State/Province
Hesse
ZIP/Postal Code
65428
Country
Germany
Facility Name
Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH
City
Aachen
State/Province
Northrhine-Westfalia
ZIP/Postal Code
52074
Country
Germany
Facility Name
Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne
City
Cologne
State/Province
Northrhine-Westfalia
ZIP/Postal Code
50937
Country
Germany
Facility Name
Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
City
Duisburg
State/Province
Northrhine-Westfalia
ZIP/Postal Code
47249
Country
Germany
Facility Name
Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf
City
Düsseldorf
State/Province
Northrhine-Westfalia
ZIP/Postal Code
40225
Country
Germany
Facility Name
Clinic of Trauma, Hand and Reconstructive Surgery
City
Münster
State/Province
Northrhine-Westfalia
ZIP/Postal Code
48149
Country
Germany
Facility Name
Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein
City
Koblenz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
56068
Country
Germany
Facility Name
Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
City
Ludwigshafen
State/Province
Rhineland-Palatinate
ZIP/Postal Code
67071
Country
Germany
Facility Name
Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms
City
Worms
State/Province
Rhineland-Palatinate
ZIP/Postal Code
67550
Country
Germany
Facility Name
Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
City
Mainz
State/Province
Rhineland-Palatine
ZIP/Postal Code
55131
Country
Germany
Facility Name
Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24606670
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.
Results Reference
background
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Cerament Treatment of Fracture Defects
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