Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

CERAMENT™|G - Bone Healing and Re-infection Prophylaxis

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: NCT02128256
Recruitment Status : Unknown
Verified December 2015 by Dr. Olivier Borens, University of Lausanne Hospitals.
Recruitment status was:  Recruiting
First Posted : May 1, 2014
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Olivier Borens, University of Lausanne Hospitals

Brief Summary:

The surgical management of long bone infections is often challenging. Adequate surgical debridement decreases the bacterial load, removes dead tissues, and gives a chance for the host immune system and antibiotics to arrest infection. Adequate debridement may leave a large bony defect. An appropriate management of the dead space is essential to arrest the disease, and for maintenance of the bone's integrity. The current strategy includes the use of antibiotic-loaded bone cement that can be used to sterilize and temporarily maintain the dead space. The cement are usually removed after 2 to 4 weeks and replaced with a cancellous graft harvested from the hip of the patient.

CERAMENT™| G is a CE-marked resorbable ceramic bone graft substitute composed by calcium sulfate and calcium hydroxyapatite, intended to fill gaps and voids in the skeleton system and to promote bone healing. The antibiotic gentamicin is included in the ceramic to prevent colonization of gentamicin-sensible microorganisms in order to protect bone healing.

The aim of this study is to investigate the device absorption and bone in-growth of CERAMENT™| G in a surgically revised bone infection. In addition, bone healing and infection non-recurrence will be evaluated during 12 months of follow-up. The investigators expect a treatment success of >90 % and that a similar bone healing will be obtained as with a standard two-stage surgical procedure. In addition, the investigators believe that the use of CERAMENT™| G will be of advantage for the patient as bone healing will be achieved with a one-stage surgical procedure (in combination with antibiotic therapy), instead of a two-stage procedure, thus decreasing potential surgery-related complications.


Condition or disease Intervention/treatment Phase
Osteomyelitis Device: Cerament G Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
Study Start Date : May 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cerament G injection
Cerament G is injected to fill a bone defect after debridement of the infected bone.
Device: Cerament G



Primary Outcome Measures :
  1. Degree of device absorption after insertion of the device (during follow-up). [ Time Frame: 3 and 12 months after surgery. ]
    The degree of device absorption will be evaluated by localized CT-scans 3 and 12 months after surgery.

  2. Advances in bone in-growth after insertion of the device (during follow up). [ Time Frame: 3 and 12 months after surgery. ]
    Bone in-growth will be evaluated by localized CT-scans 3 and 12 months after surgery.


Secondary Outcome Measures :
  1. Bone healing [ Time Frame: 6 weeks, 3 months, 6 months and 12 months after surgery. ]
    Bone healing will be evaluated by X-ray 6 weeks, 3 months, 6 months and 12 months after surgery.

  2. Infection non-recurrence [ Time Frame: During hospitalisation and 6 weeks, 3 months, 6 months and 12 months after surgery. ]
    Infection non-recurrence will be verified by measuring inflammatory blood parameters and body temperature, and through clinical examination (looking for pain, swelling, warmth and redness) during hospitalization (an expected average of 14 days following the surgery), and 6 weeks, 3 months, 6 months and 12 months after surgery (i.e. at each follow-up visit according to standard clinical praxis).

  3. Serum gentamicin levels [ Time Frame: 24 h, 48 h and 72 h after surgery. ]
    For evaluation of the gentamicin elution from the ceramic, serum gentamicin levels will be measured 24 h, 48 h and 72 h after surgery (during hospitalisation).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a long bone infection in femur, tibia, humerus or radius
  • Candidate for one stage procedure
  • Patients above the age of 18
  • 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:

  • Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
  • Hypersensitivity to aminoglycoside antibiotics
  • Myasthenia gravis
  • Severe renal impairment
  • Pre existing calcium metabolism disorder.
  • Women who are pregnant or breastfeeding (a pregnancy test will be done in women of childbearing potential)
  • History of hypersensitivity to the investigational device or any of its ingredients

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): NCT02128256


Contacts
Layout table for location contacts
Contact: Olivier Borens, MD 00 41 21 314 27 89 olivier.borens@chuv.ch

Locations
Layout table for location information
Switzerland
Lausanne University Hospital, Service of Orthopedy and Traumatology Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Olivier Borens, MD    00 41 21 314 27 89    olivier.borens@chuv.ch   
Principal Investigator: Olivier Borens, MD         
Sponsors and Collaborators
Dr. Olivier Borens

Layout table for additonal information
Responsible Party: Dr. Olivier Borens, Head of Service of Traumatology and Septic Surgical Unit, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02128256     History of Changes
Other Study ID Numbers: CeramentG-CH-2014
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015

Keywords provided by Dr. Olivier Borens, University of Lausanne Hospitals:
Osteomyelitis
Bone substitute
Ceramic
Gentamicin

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteomyelitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases