AO 41-B2 and AO 41-B3 Tibia FracturesCERTiFyNCT01828905
Cerament Treatment of Fracture Defects
A study testing CERAMENT™|BONE VOID FILLER and Autologous cancellous bone graft in people with AO 41-B2 and AO 41-B3 Tibia Fractures, run by Johannes Gutenberg University Mainz at 16 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AO 41-B2 and AO 41-B3 Tibia Fractures
- What is being tested?
- CERAMENT™|BONE VOID FILLER and Autologous cancellous bone graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 16 sitesGermany
- Study dates
- Apr 2013to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with multiple injuries
- polytrauma patients
- compartment syndrome
- previous iliac crest bone graft harvesting
- local infection at the site of implantation
- chronic pain disease
Show all 19Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Germany16 sites
Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH
Aachen, Northrhine-Westfalia, 52074
Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH
Bad Homburg, Hesse, 61348
Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne
Cologne, Northrhine-Westfalia, 50937
Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
Duisburg, Northrhine-Westfalia, 47249
Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf
Düsseldorf, Northrhine-Westfalia, 40225
Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt
Frankfurt am Main, Hesse, 60590
Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg
Freiburg im Breisgau, Geogr. Baden-Wuerttemberg, 79106
Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda
Fulda, Hesse, 36043
Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein
Koblenz, Rhineland-Palatinate, 56068
Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck
Lübeck, Schleswig-Holstein, 23538
Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
Ludwigshafen am Rhein, Rhineland-Palatinate, 67071
Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatine, 55131
Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar)
München, Bavaria, 81675
Clinic of Trauma, Hand and Reconstructive Surgery
Münster, Northrhine-Westfalia, 48149
Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR)
Rüsselsheim am Main, Hesse, 65428
Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms
Worms, Rhineland-Palatinate, 67550
About this study
Official title: A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures
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.
- Conditions
- AO 41-B2 and AO 41-B3 Tibia Fractures
- Being tested
- CERAMENT™|BONE VOID FILLER, Autologous cancellous bone graft
- Keywords
- tibia fracture, bone graft, iliac crest, bone graft substitute, Cerament, void filler, quality of life, pain, costs of care
- Medical subject headings
- Tibial Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERAMENT™|BONE VOID FILLERDevice
ceramic bone void filler
Autologous cancellous bone graftProcedure or surgery
autologous cancellous bone graft
| Study group | Role | What they receive |
|---|---|---|
| Cerament | Experimental | CERAMENT™|BONE VOID FILLER as bone graft substitute Receives: Device: CERAMENT™|BONE VOID FILLER |
| Bone graft | Active comparator | Autologous cancellous bone graft (iliac crest) Receives: Procedure: Autologous cancellous bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-12 Physical Component Summary (PCS) at week 26
Measured: 26 weeks
Global pain VAS score at week 26
Measured: 26 weeks
Secondary outcomes (6)
Utilisation of costs of care related resources
Measured: 26 weeks
SF-12 PCS and MCS at visit 4
Measured: 1 week
Bone healing
Evaluated by X-ray
Measured: 1, 6, 12 and 26 weeks
SF-12 PCS and MCS at visit 5
Measured: 6 weeks
SF-12 PCS and MCS at visit 6
Measured: 12 weeks
SF-12 PCS and MCS at visit 7
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completion24 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AO 41-B2 and AO 41-B3 Tibia FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ.-Prof. Pol M. Rommens, Johannes Gutenberg University Mainz
- Investigators
- Pol M. Rommens, Univ.-Prof., MD, Principal investigator, Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828905
- Sponsor's protocol ID
- S041/2012
- Acronym
- CERTiFy
- Status last verified
- Mar 2019
- First submitted
- 4 Apr 2013
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24606670
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures
- ClinicalTrials.gov ID
- NCT01828905
- Acronym / sponsor ID
- CERTiFy / S041/2012
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 24 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerament | Experimental | Device: CERAMENT™|BONE VOID FILLERCERAMENT™|BONE VOID FILLER as bone graft substitute |
| Bone graft | Active comparator | Procedure: Autologous cancellous bone graftAutologous cancellous bone graft (iliac crest) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- patients with multiple injuries
- polytrauma patients
- compartment syndrome
- previous iliac crest bone graft harvesting
- local infection at the site of implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CERAMENT™|BONE VOID FILLERceramic bone void filler | Device | Cerament |
| Autologous cancellous bone graftautologous cancellous bone graft | Procedure or surgery | Bone graft |
Primary outcome
SF-12 Physical Component Summary (PCS) at week 26
Time frame: 26 weeks
Global pain VAS score at week 26
Time frame: 26 weeks
6 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Background: PubMed 24606670Nusselt 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pol M. Rommens, Univ.-Prof., MD principal investigator
Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CERAMENT™|BONE VOID FILLER and Autologous cancellous bone graft in people with AO 41-B2 and AO 41-B3 Tibia Fractures, run by Johannes Gutenberg University Mainz at 16 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-12 Physical Component Summary (PCS) at week 26 (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01828905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.