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Cerament Treatment of Fracture Defects (CERTiFy)

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
Sponsor:
Information provided by (Responsible Party):
Univ.-Prof. Pol M. Rommens, Johannes Gutenberg University Mainz

Study Description
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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.

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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. SF-12 Physical Component Summary (PCS) at week 26 [ Time Frame: 26 weeks ]
  2. Global pain VAS score at week 26 [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Utilisation of costs of care related resources [ Time Frame: 26 weeks ]
  2. SF-12 PCS and MCS at visit 4 [ Time Frame: 1 week ]
  3. Bone healing [ Time Frame: 1, 6, 12 and 26 weeks ]
    Evaluated by X-ray

  4. SF-12 PCS and MCS at visit 5 [ Time Frame: 6 weeks ]
  5. SF-12 PCS and MCS at visit 6 [ Time Frame: 12 weeks ]
  6. SF-12 PCS and MCS at visit 7 [ Time Frame: 26 weeks ]

Other Outcome Measures:
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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Principal Investigator: Pol M. Rommens, Univ.-Prof., MD Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
More Information
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Publications:

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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
Keywords provided by Univ.-Prof. Pol M. Rommens, Johannes Gutenberg University Mainz:
tibia fracture
bone graft
iliac crest
bone graft substitute
Cerament
 void filler
quality of life
pain
costs of care
Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries