CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
Primary Purpose
Osteomyelitis
Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Cerament G
Sponsored by
About this trial
This is an interventional treatment trial for Osteomyelitis focused on measuring Osteomyelitis, Bone substitute, Ceramic, Gentamicin
Eligibility 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
Sites / Locations
- Lausanne University Hospital, Service of Orthopedy and TraumatologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cerament G injection
Arm Description
Cerament G is injected to fill a bone defect after debridement of the infected bone.
Outcomes
Primary Outcome Measures
Degree of device absorption after insertion of the device (during follow-up).
The degree of device absorption will be evaluated by localized CT-scans 3 and 12 months after surgery.
Advances in bone in-growth after insertion of the device (during follow up).
Bone in-growth will be evaluated by localized CT-scans 3 and 12 months after surgery.
Secondary Outcome Measures
Bone healing
Bone healing will be evaluated by X-ray 6 weeks, 3 months, 6 months and 12 months after surgery.
Infection non-recurrence
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).
Serum gentamicin levels
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02128256
Brief Title
CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
Official Title
CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Olivier Borens
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteomyelitis
Keywords
Osteomyelitis, Bone substitute, Ceramic, Gentamicin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cerament G injection
Arm Type
Experimental
Arm Description
Cerament G is injected to fill a bone defect after debridement of the infected bone.
Intervention Type
Device
Intervention Name(s)
Cerament G
Primary Outcome Measure Information:
Title
Degree of device absorption after insertion of the device (during follow-up).
Description
The degree of device absorption will be evaluated by localized CT-scans 3 and 12 months after surgery.
Time Frame
3 and 12 months after surgery.
Title
Advances in bone in-growth after insertion of the device (during follow up).
Description
Bone in-growth will be evaluated by localized CT-scans 3 and 12 months after surgery.
Time Frame
3 and 12 months after surgery.
Secondary Outcome Measure Information:
Title
Bone healing
Description
Bone healing will be evaluated by X-ray 6 weeks, 3 months, 6 months and 12 months after surgery.
Time Frame
6 weeks, 3 months, 6 months and 12 months after surgery.
Title
Infection non-recurrence
Description
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).
Time Frame
During hospitalisation and 6 weeks, 3 months, 6 months and 12 months after surgery.
Title
Serum gentamicin levels
Description
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).
Time Frame
24 h, 48 h and 72 h after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Borens, MD
Phone
00 41 21 314 27 89
Email
olivier.borens@chuv.ch
Facility Information:
Facility Name
Lausanne University Hospital, Service of Orthopedy and Traumatology
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Borens, MD
Phone
00 41 21 314 27 89
Email
olivier.borens@chuv.ch
First Name & Middle Initial & Last Name & Degree
Olivier Borens, MD
12. IPD Sharing Statement
Learn more about this trial
CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
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