Osteomyelitis Clinical Trial
Official title:
CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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