NCT02128256

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

April 23, 2014

Last Update Submit

December 1, 2015

Conditions

Osteomyelitis

Keywords

OsteomyelitisBone substituteCeramicGentamicin

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 and 12 months after surgery.

Secondary Outcomes (3)

  • Bone healing

    6 weeks, 3 months, 6 months and 12 months after surgery.

  • Infection non-recurrence

    During hospitalisation and 6 weeks, 3 months, 6 months and 12 months after surgery.

  • Serum gentamicin levels

    24 h, 48 h and 72 h after surgery.

Study Arms (1)

Cerament G injection

EXPERIMENTAL

Cerament G is injected to fill a bone defect after debridement of the infected bone.

Device: Cerament G

Interventions

Cerament GDEVICE
Cerament G injection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital, Service of Orthopedy and Traumatology

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Olivier Borens, MD

CONTACT

00 41 21 314 27 89olivier.borens@chuv.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Service of Traumatology and Septic Surgical Unit

Study Record Dates

First Submitted

April 23, 2014

First Posted

May 1, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

CH(1)