Cerament Treatment of Fracture Defects (CERTiFy)

March 1, 2019 updated by: Univ.-Prof. Pol M. Rommens, Johannes Gutenberg University Mainz

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • München, Bavaria, Germany, 81675
        • Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar)
    • Geogr. Baden-Wuerttemberg
      • Freiburg, Geogr. Baden-Wuerttemberg, Germany, 79106
        • Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg
    • Hesse
      • Bad Homburg, Hesse, Germany, 61348
        • Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH
      • Frankfurt, Hesse, Germany, 60590
        • Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt
      • Fulda, Hesse, Germany, 36043
        • Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda
      • Rüsselsheim, Hesse, Germany, 65428
        • Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR)
    • Northrhine-Westfalia
      • Aachen, Northrhine-Westfalia, Germany, 52074
        • Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH
      • Cologne, Northrhine-Westfalia, Germany, 50937
        • Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne
      • Duisburg, Northrhine-Westfalia, Germany, 47249
        • Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
      • Düsseldorf, Northrhine-Westfalia, Germany, 40225
        • Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf
      • Münster, Northrhine-Westfalia, Germany, 48149
        • Clinic of Trauma, Hand and Reconstructive Surgery
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 56068
        • Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein
      • Ludwigshafen, Rhineland-Palatinate, Germany, 67071
        • Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik)
      • Worms, Rhineland-Palatinate, Germany, 67550
        • Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms
    • Rhineland-Palatine
      • Mainz, Rhineland-Palatine, Germany, 55131
        • Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
SF-12 Physical Component Summary (PCS) at week 26
Time Frame: 26 weeks
26 weeks
Global pain VAS score at week 26
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Utilisation of costs of care related resources
Time Frame: 26 weeks
26 weeks
SF-12 PCS and MCS at visit 4
Time Frame: 1 week
1 week
Bone healing
Time Frame: 1, 6, 12 and 26 weeks
Evaluated by X-ray
1, 6, 12 and 26 weeks
SF-12 PCS and MCS at visit 5
Time Frame: 6 weeks
6 weeks
SF-12 PCS and MCS at visit 6
Time Frame: 12 weeks
12 weeks
SF-12 PCS and MCS at visit 7
Time Frame: 26 weeks
26 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johannes Gutenberg University Mainz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pol M. Rommens, Univ.-Prof., MD, Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 24, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S041/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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