Clinical trial NCT02128256: CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
Official title: CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteomyelitis
Keywords: Osteomyelitis
Bone substitute
Ceramic
Gentamicin
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Degree of device absorption after insertion of the device (during follow-up).
timeFrame: 3 and 12 months after surgery.
measure: Advances in bone in-growth after insertion of the device (during follow up).
timeFrame: 3 and 12 months after surgery.
Secondary outcomes:
measure: Bone healing
timeFrame: 6 weeks, 3 months, 6 months and 12 months after surgery.
measure: Infection non-recurrence
timeFrame: During hospitalisation and 6 weeks, 3 months, 6 months and 12 months after surgery.
measure: Serum gentamicin levels
timeFrame: 24 h, 48 h and 72 h after surgery.
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital, Service of Orthopedy and Traumatology
state: Vaud
Study officials:
References: