CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Cerament G injection
Cerament G is injected to fill a bone defect after debridement of the infected bone.
Device: Cerament G
- 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.
- 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.
- 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).
- 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).
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
|Contact: Olivier Borens, MD||00 41 21 314 27 email@example.com|
|Lausanne University Hospital, Service of Orthopedy and Traumatology||Recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Olivier Borens, MD 00 41 21 314 27 89 firstname.lastname@example.org|
|Principal Investigator: Olivier Borens, MD|