Using a bone substitute to treat chronic bone infections
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
This study is testing a new bone substitute that releases medication to see if it can help people with chronic bone infections heal better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 15 sites (Amiens and 14 other locations) |
| Trial ID | NCT04805164 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a bone substitute called Cerament-G, which delivers gentamicin, in treating chronic osteomyelitis affecting long bones such as the tibia, femur, and humerus. The approach involves performing a corticotomy to access the infected bone, allowing for the identification and removal of bacteria and infected tissue. The Cerament-G device is then used to help eradicate the infection and promote healing. This method aims to address the challenges posed by bacteria that can form biofilms, making them difficult to treat with standard therapies.
Who should consider this trial
Good fit: Ideal candidates include patients with suspected chronic osteomyelitis of long bones, exhibiting specific clinical and radiological signs of infection.
Not a fit: Patients without chronic osteomyelitis or those with other underlying conditions that complicate treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients suffering from chronic osteomyelitis and reduce the need for more invasive procedures like amputation.
How similar studies have performed: While the specific use of Cerament-G for this condition may be novel, similar approaches using local antibiotic delivery systems have shown promise in treating chronic infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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
Exclusion Criteria:
* 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;
* 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.
Where this trial is running
Amiens and 14 other locations
- CHU Amiens-Picardie — Amiens, France (Recruiting)
- CHU de Besançon — Besançon, France (Not_yet_recruiting)
- CHU Bordeaux — Bordeaux, France (Recruiting)
- Aphp — Boulogne-Billancourt, France (Not_yet_recruiting)
- CHU Brest — Brest, France (Recruiting)
- CHU de Caen — Caen, France (Recruiting)
- CHU de Lille — Lille, France (Not_yet_recruiting)
- Hospices Civils de Lyon — Lyon, France (Recruiting)
- Hospices Civils de Lyon — Lyon, France (Not_yet_recruiting)
- CHRU Nancy — Nancy, France (Not_yet_recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Not_yet_recruiting)
- Hospices Civils de Lyon — Pierre-Bénite, France (Recruiting)
- CHU de Poitiers — Poitiers, France (Not_yet_recruiting)
- CHU de Toulouse — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Tristan FERRY
- Email: tristan.ferry@chu-lyon.fr
- Phone: +33 4 72 07 24 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.