OsteomyelitisPhase 4NCT02128256
CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
A Phase 4 study testing Cerament G in people with Osteomyelitis, run by Dr. Olivier Borens at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteomyelitis
- What is being tested?
- Cerament G
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2014to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital, Service of Orthopedy and Traumatology
Lausanne, Canton of Vaud, 1011
Olivier Borens, MD, 00 41 21 314 27 89, olivier.borens@chuv.ch
Olivier Borens, MD
About this study
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.
- Conditions
- Osteomyelitis
- Being tested
- Cerament G
- Keywords
- Osteomyelitis, Bone substitute, Ceramic, Gentamicin
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerament GDevice
| Study group | Role | What they receive |
|---|---|---|
| Cerament G injection | Experimental | Cerament G is injected to fill a bone defect after debridement of the infected bone. Receives: Device: Cerament G |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 and 12 months after surgery.
Secondary outcomes (3)
Bone healing
Bone healing will be evaluated by X-ray 6 weeks, 3 months, 6 months and 12 months after surgery.
Measured: 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).
Measured: During hospitalisation and 6 weeks, 3 months, 6 months and 12 months after surgery.
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).
Measured: 24 h, 48 h and 72 h after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Olivier Borens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Olivier Borens, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128256
- Sponsor's protocol ID
- CeramentG-CH-2014
- Status last verified
- Dec 2015
- First submitted
- 23 Apr 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
- ClinicalTrials.gov ID
- NCT02128256
- Acronym / sponsor ID
- CeramentG-CH-2014
- Conditions
- Osteomyelitis
- Keywords
- Osteomyelitis, Bone substitute, Ceramic, Gentamicin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Dr. Olivier BorensUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerament G injection | Experimental | Device: Cerament GCerament G is injected to fill a bone defect after debridement of the infected bone. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerament G | Device | Cerament G injection |
Primary outcome
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.
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.
3 secondary outcomes
Bone healing
Time frame: 6 weeks, 3 months, 6 months and 12 months after surgery.
Infection non-recurrence
Time frame: During hospitalisation and 6 weeks, 3 months, 6 months and 12 months after surgery.
Serum gentamicin levels
Time frame: 24 h, 48 h and 72 h after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cerament G in people with Osteomyelitis, run by Dr. Olivier Borens at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Borens, MD (00 41 21 314 27 89, olivier.borens@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of device absorption after insertion of the device (during follow-up). (time frame: 3 and 12 months after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.