Osteomyelitis ChronicCONVICTIONNCT04805164
Evaluation of the Efficiency of the Bone Substitute Cerament-G Locally Delivering Gentamicin in the Treatment of Chronic Osteomyelitis of Long Bones
A study testing Corticotomy and use of the bone substitute : Cerament-G device. and Corticotomy in people with Osteomyelitis Chronic, run by Hospices Civils de Lyon at 15 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteomyelitis Chronic
- What is being tested?
- Corticotomy and use of the bone substitute : Cerament-G device. and Corticotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 15 sitesFrance
- Study dates
- 14 Oct 2021to 14 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 23Show fewer
- 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 bacterium(s) involved) and secondary intramedullary residual cavity;
- 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
Who cannot join
- 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 interventional study that could interfere with it;
Show all 11Show fewer
- 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 formula, or GFR < 30 ml/min/1.73² according to the CKD-EPI or MDRDs equation or, dialysis patient), pre-existing disorders of calcium metabolism (total plasma calcium (or total corrected plasma calcium according to albuminemia) outside normal laboratory values);
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU Amiens-Picardie
Amiens, 80054
CHU de Besançon
Besançon, 25030
CHU Bordeaux
Bordeaux, 33076
APHP
Boulogne-Billancourt, 92104
CHU Brest
Brest, 29200
CHU de Caen
Caen, 14033
CHU de Lille
Lille, 59037
Hospices Civils de Lyon
Lyon, 69004
Hospices Civils de Lyon
Lyon, 69437
CHRU Nancy
Nancy, 54000
CHU de Nantes
Nantes, 44093
CHU de Nîmes
Nîmes, 30029
Hospices Civils de Lyon
Pierre-Bénite, 69310
CHU de Poitiers
Poitiers, 86021
CHU de Toulouse
Toulouse, 31059
About this study
Official title: Evaluation of the Efficiency of the Bone Substitute Cerament-G Locally Delivering Gentamicin in the Treatment of Chronic Osteomyelitis of Long Bones: Randomized Multicentre Study in the CRIOAc Network - CONVICTION Study
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.
Read more
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.
- Conditions
- Osteomyelitis Chronic
- Being tested
- Corticotomy and use of the bone substitute : Cerament-G device., Corticotomy
- Keywords
- Bone infection, chronic osteomyelitis, bone substitute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticotomy and use of the bone substitute : Cerament-G device.Procedure or surgery
Corticotomy and Cerament-G device
CorticotomyProcedure or surgery
Corticotomy
| Study group | Role | What they receive |
|---|---|---|
| Innovative strategy | Experimental | 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. Receives: Procedure: Corticotomy and use of the bone substitute : Cerament-G device. |
| Reference strategy | Active comparator | Medico-surgical usual care with corticotomy (± skin and soft-tissue/muscle flap), and antibiotic therapy. Receives: Procedure: Corticotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cost-Utility Ratio (ICUR) between the two treatments strategies for chronic long bone osteomyelitis
Measured: At 24 months (M24)
Secondary outcomes (12)
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.
Measured: 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
Measured: 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
Measured: From first surgery to 24 months (M24)
Proportion of patients with amputations
Proportion of patients with amputation of the area containing the bone studied.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: At 24 months (M24)
Real cost
Real cost associated of a corticotomy procedure using Cerament-G
Measured: 24 months (M24)
Estimated utility
Estimated utility measured with the EQ-5D (EuroQol Group-5 dimensions) questionnaire.
Measured: 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
Measured: At 24 months (M24)
Budgetary impact analysis
Budgetary impact analysis carried out from the perspective of the French Health Insurance.
Measured: 24 months (M24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start14 Oct 2021
- Primary completion14 Nov 2027 (estimated)
- Study completion14 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis ChronicStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805164
- Sponsor's protocol ID
- 69HCL20_0065
- Other IDs
- 2020-A02299-30
- Acronym
- CONVICTION
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of the Bone Substitute Cerament-G Locally Delivering Gentamicin in the Treatment of Chronic Osteomyelitis of Long Bones: Randomized Multicentre Study in the CRIOAc Network - CONVICTION Study
- ClinicalTrials.gov ID
- NCT04805164
- Acronym / sponsor ID
- CONVICTION / 69HCL20_0065
- Conditions
- Osteomyelitis Chronic
- Keywords
- Bone infection, chronic osteomyelitis, bone substitute
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 14 Nov 2027 (estimated)
- Study completion
- 14 Nov 2027 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innovative strategy | Experimental | Procedure: Corticotomy and use of the bone substitute : Cerament-G device.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. |
| Reference strategy | Active comparator | Procedure: CorticotomyMedico-surgical usual care with corticotomy (± skin and soft-tissue/muscle flap), and antibiotic therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
- 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 bacterium(s) involved) and secondary intramedullary residual cavity;
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticotomy and use of the bone substitute : Cerament-G device.Corticotomy and Cerament-G device | Procedure or surgery | Innovative strategy |
| CorticotomyCorticotomy | Procedure or surgery | Reference strategy |
Primary outcome
Incremental Cost-Utility Ratio (ICUR) between the two treatments strategies for chronic long bone osteomyelitis
Time frame: At 24 months (M24)
12 secondary outcomes
Recurrence of bone infection
Time frame: At 24 months (M24)
Intraoperative and Postoperative complications
Time frame: From inclusion to 24 months (M24)
Repeated surgeries for complication
Time frame: From first surgery to 24 months (M24)
Proportion of patients with amputations
Time frame: At 24 months (M24)
Bone healing and bone remodelling/consolidation
Time frame: At 12 months (M12)
Serious Adverse Events (SAEs) attributable to systemic antibiotic therapy.
Time frame: Within 3 months of the first intervention (M3)
Acute renal failure
Time frame: Within 3 months of the first procedure (M3)
Adverse Events related to the use of Cerament-G
Time frame: At 24 months (M24)
Real cost
Time frame: 24 months (M24)
Estimated utility
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
Time frame: At 24 months (M24)
Budgetary impact analysis
Time frame: 24 months (M24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Related trials for Osteomyelitis Chronic
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 2
EFFICACY AND SAFETY OF ZOLEDRONATE VERSUS PLACEBO ON PAIN AT WEEK 12 IN PEDIATRIC PATIENTS WITH CHRONIC RECURRENT MULTIFOCAL OSTEOMYELITIS
Osteomyelitis Chronic
RecruitingObservational study
Reliability and Validation of the WB-MRI Radiological Score in CRMO
Chronic Recurrent Multifocal Osteomyelitis, Pediatrics
RecruitingObservational study
CERAMENT G Device Registry
Chronic Osteomyelitis, Fracture Related Infection
Recruiting
Additional Hyperbaric Oxygen After Lower Extremity Amputation
Diabetes Mellitus, Claudication, Intermittent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticotomy and use of the bone substitute : Cerament-G device. and Corticotomy in people with Osteomyelitis Chronic, run by Hospices Civils de Lyon at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Cost-Utility Ratio (ICUR) between the two treatments strategies for chronic long bone osteomyelitis (time frame: At 24 months (M24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.