An interventional study of Corticotomy and use of the bone substitute : Cerament-G device. and Corticotomy in Osteomyelitis Chronic, sponsored by Hospices Civils de Lyon. Active, not recruiting at 15 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
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.
Chronic osteomyelitis can have a hematogenous or more often exogenous origin, after trauma or surgery. The bacteria involved have the ability to modify their metabolism and involve persistence mechanisms (such as biofilm) making them difficult to eradicate. The treatment of chronic osteomyelitis requires surgery, i.e. corticotomy, which means opening of the bone cortex to perform an endomedullary curettage to identify the bacteria, remove any sequestration (bone fragments to which the bacteria adhere as biofilm) and reduce the bacterial inoculum. At the same time, or at a second stage, a skin and soft tissue/muscle flap may be required, especially in patients with long-standing disease with embrittlement and adhesion of the skin and soft tissue to the underlying bone.
Post-operatively, the patient receives a probabilistic systemic antibiotic therapy and then a systemic antibiotic therapy targeted on the identified germ, for a period of 3 months. The effectiveness of these antibiotics is based on their ability to penetrate bone tissue. Despite the progress made in both antibiotics and surgical treatments, the probability of failure (recurrence of infection) is around 20%, and has unfortunately remained stable for more than 20 years.
Cerament-G (BONESUPPORT AB Laboratory, Sweden), a synthetic bone substitute composed of hydroxyapatite, calcium sulphate, and gentamicin, fills the "dead space" formed during surgery, prevents infection of this blood-filled cavity, and promotes bone regeneration within this space (limiting the risk of fracture in the medium and long term). Cerament-G also delivers locally very high doses of gentamicin (concentration of 17.5 mg/mL in the device) for several weeks. Gentamicine is a broad-spectrum bactericidal antibiotic effective against the vast majority of bacteria involved in osteoarticular infections. It provides effective local antibiotic therapy through wide exposure and prolonged concentrations during several weeks.
To date, there is no other bone substitute with antibiotics available in France. Two prospective studies have shown that Cerament-G reduces the number of infectious recurrences (about 5%).
This innovation is available in France but at a high price (between 2,500 and 4,000 euros) and is not currently reimbursed. However, the use of this product would make it possible to improve the health and quality of life of patients while avoiding certain consumption of resources.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's planned enrollment of 220 is above the median of 74 across 60 interventional studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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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:
At least one of the following clinical signs at the suspected infected site:
At least one of the following radiological signs at the suspected infected site:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
usual medical and surgical care with corticotomy and use of a bone substitute (Cerament-G) delivering gentamicin locally (± skin and soft-tissue/muscle flap) and antibiotic therapy.
Procedure: Corticotomy and use of the bone substitute : Cerament-G device.
Medico-surgical usual care with corticotomy (± skin and soft-tissue/muscle flap), and antibiotic therapy.
Procedure: Corticotomy
Corticotomy and Cerament-G device
Corticotomy
Incremental Cost-Utility Ratio (ICUR) between the two treatments strategies for chronic long bone osteomyelitis
Time frame: At 24 months (M24)
Recurrence of bone infection
Proportion of patients with at least one recurrence of infection on the studied bone and time to recurrence. The Event Validation Committee will confirm the recurrence of infection.
Time frame: At 24 months (M24)
Intraoperative and Postoperative complications
Number and types of intraoperative and postoperative complications up to 24 months (including fracture) according to CTCAE and Clavien-Dindo classifications; and proportion of patients with at least one complication during follow-up
Time frame: From inclusion to 24 months (M24)
Repeated surgeries for complication
Number of repeat surgeries for complication up to 24 months; and proportion of patients who had at least one repeat surgery for complication during follow-up
Time frame: From first surgery to 24 months (M24)
Proportion of patients with amputations
Proportion of patients with amputation of the area containing the bone studied.
Time frame: At 24 months (M24)
Bone healing and bone remodelling/consolidation
Proportion of patients with bone healing and proportion of patients with bone remodelling/consolidation, assessed from a standard radiograph (confirmed by the Event Validation Committee).
Time frame: At 12 months (M12)
Serious Adverse Events (SAEs) attributable to systemic antibiotic therapy.
Number and types of serious adverse events (SAEs) attributable to systemic antibiotic therapy following the first intervention; and proportion of patients with at least one SAE attributable to this systemic antibiotic therapy; within 3 months of the first intervention.
Time frame: Within 3 months of the first intervention (M3)
Acute renal failure
Proportion of patients with acute renal failure within 3 months of the first procedure
Time frame: Within 3 months of the first procedure (M3)
Adverse Events related to the use of Cerament-G
Cost of both strategies estimated at 24 months
Time frame: At 24 months (M24)
Real cost
Real cost associated of a corticotomy procedure using Cerament-G
Time frame: 24 months (M24)
Estimated utility
Estimated utility measured with the EQ-5D (EuroQol Group-5 dimensions) questionnaire.
Time frame: At inclusion, at Week 4/Week 6, Month 3, Month 6, Month12, Month 18 and Month 24 (usual follow-up visits) as well as after each repeat surgery according to the same schedule
Estimated incremental cost-effectiveness ratio
Estimated incremental cost-effectiveness ratio with no recurrence of infection as efficacy endpoint
Time frame: At 24 months (M24)
Budgetary impact analysis
Budgetary impact analysis carried out from the perspective of the French Health Insurance.
Time frame: 24 months (M24)
Started Oct 2021 (actual). Primary completion is estimated for Nov 2027, 73 months after the start.
Of 21 interventional studies with no phase under Osteomyelitis, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 69. This study's planned 73 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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