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New treatment option for Osteomyelitis Chronic
Official title Evaluation of the Efficiency of the Bone Substitute Cerament-G Locally Delivering Gentamicin in the Treatment of Chronic Osteomyelitis of Long Bones
ClinicalTrials.gov ID: NCT04805164
What this study is testing
- What it's testing
- Chronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones (tibia, femur, humerus), responsible for significant morbidity with risk of fracture and amputation. It is due to the presence of bacteria in the bone marrow, sometimes responsible for an intraosseous abscess.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patient with suspected chronic osteomyelitis (stage III of the Cierny-Mader classification) of a long bone of the tibia, femur, humerus or forearm...
- Supposed inoculation \> 3 months ;
- At least one of the following clinical signs at the suspected infected site:
- Spontaneous or supporting pain ;
- Presence of fistula; or history of fistula discharge
You likely can't join if
- Acute hematogenic osteomyelitis (Cierny-Mader stage I) ;
- Cortical osteitis (Cierny-Mader stage II);
- Septic pseudoarthrosis (Cierny-Mader stage IV);
- Patient requiring an estimated skin and soft-tissue/muscle flap that cannot be done within 15 days after surgery for the treatment of chronic...
- Woman who is pregnant, nursing or who is considering becoming pregnant during the study period;
- Patient participating in another treatment study that could interfere with it;
See the full eligibility criteria
- Patient with suspected chronic osteomyelitis (stage III of the Cierny-Mader classification) of a long bone of the tibia, femur, humerus or forearm, at the diaphysis, metaphysis or epiphysis, defined as follows:
- Supposed inoculation \> 3 months ;
- At least one of the following clinical signs at the suspected infected site:
- Spontaneous or supporting pain ;
- Presence of fistula; or history of fistula discharge
- Presence of serous or purulent flow;
- Presence of bone exposure;
- Local Inflammation;
- Fever in the absence of any other explanation.
- At least one of the following radiological signs at the suspected infected site:
- Bone reshaping with osteolysis or periosteal apposition;
- Presence of intramedullary abscess (if MRI performed);
- Presence of a fistulous pathway to the intramedullary (if MRI performed);
- Presence of bone sequestration visible on CT scan (if CT scan performed).
- Patient in whom conventional surgical treatment of chronic osteomyelitis is possible, with decortication and corticotomy with endomedullary curettage (to eradicate bone sequestrums, reduce the inoculum, and identify the...
- Patient in whom 3 months of systemic antibiotic therapy post-operatively are planned;
- If osteosynthetic material is present in the infection site, this material should be considered preoperatively as completely removable during chronic osteomyelitis surgery;
- Patient in whom a direct closure without tension is possible, or in whom a skin and soft-tissue/muscle flap can be performed within 15 days after the initial surgery;
- Male or female patient between 18 and 80 years of age;
- Patient who has given written informed consent to participate in the study;
- Geographically stable patient;
- Patient able to comply with follow-up visits, protocol schedule and therapeutic treatment, according to investigator's judgement;
- Affiliated patient or beneficiary of a social security system
- Acute hematogenic osteomyelitis (Cierny-Mader stage I) ;
- Cortical osteitis (Cierny-Mader stage II);
- Septic pseudoarthrosis (Cierny-Mader stage IV);
- Patient requiring an estimated skin and soft-tissue/muscle flap that cannot be done within 15 days after surgery for the treatment of chronic osteomyelitis;
- Woman who is pregnant, nursing or who is considering becoming pregnant during the study period;
- Patient participating in another treatment study that could interfere with it;
- Patient known to have hypersensitivity to aminoglycosides (especially gentamicin), sulfites (including calcium sulfate) or calcium hydroxyapatite;
- Contraindication to the use of Cerament-G: severe myasthenia (class IV or higher according to the MGFA classification), , severe renal insufficiency (creatinine clearance \<30 mL/min according to the Cockcroft-Gault...
- Patient with endocrine or metabolic disorders known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, hyperthyroidism, parathyroid disorder, Ehler-Danlos syndrome, osteogenesis imperfecta);
- Patient with one or more untreated malignant cancers (including Marjolin's ulcer), or undergoing radiotherapy or chemotherapy;
- Adult patient protected by law, under guardianship or trusteeship.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Besançon, France
- Bordeaux, France
- Boulogne-Billancourt, France
- Brest, France
- Caen, France
- Lille, France
- Lyon, France
- Nancy, France
- Nantes, France
- Nîmes, France
- Pierre-Bénite, France
- Poitiers, France
- Toulouse, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Besançon, France; Bordeaux, France; Boulogne-Billancourt, France; Brest, France; Caen, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.