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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • 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

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
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

What is the study measuring?

Primary Outcome Measures

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

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

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

Johannes Gutenberg University Mainz

Investigators

  • 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

April 1, 2013

Primary Completion (Actual)

December 24, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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