Cost-effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones: Protocol for the CONVICTION randomized multicenter study
IntroductionChronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones, responsible for significant morbidity with the risk of fracture and amputation. Despite advances in both antibiotics and surgical treatment, the probability of recurrence of infection re...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-03-01
|
| Series: | Frontiers in Medicine |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2023.1116711/full |
| _version_ | 1797856339650674688 |
|---|---|
| author | Hassan Serrier Laure Huot Laure Huot Sophie Brosset Sophie Brosset Cécile Batailler Cécile Batailler Cécile Batailler Tristan Ferry Tristan Ferry Tristan Ferry Tristan Ferry |
| author_facet | Hassan Serrier Laure Huot Laure Huot Sophie Brosset Sophie Brosset Cécile Batailler Cécile Batailler Cécile Batailler Tristan Ferry Tristan Ferry Tristan Ferry Tristan Ferry |
| author_sort | Hassan Serrier |
| collection | DOAJ |
| description | IntroductionChronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones, responsible for significant morbidity with the risk of fracture and amputation. Despite advances in both antibiotics and surgical treatment, the probability of recurrence of infection remains at around 20%. Cerament-G (BONESUPPORT AB, Sweden) is a synthetic bone substitute that fills the bone void left by surgery, prevents infection and promotes bone regeneration within this space. Cerament-G also provides the local delivery of high doses of gentamicin over several weeks. Two prospective observational studies described a number of infectious recurrences of 4 and 5% after the use of Cerament-G. Although available in France, Cerament-G is currently not reimbursed and its high cost constitutes a barrier to its use. We hypothesize that the use of Cerament-G will lead to fewer costs to the collectivity while improving patient utility and, as an innovative strategy, will be superior to standard of care on recurrence of infection.Methods and analysisThe Conviction Study is a prospective, multicenter, randomized, single blind study conducted in 14 French Reference Centers for Complex Osteoarticular infections. The main objective is to evaluate the cost-effectiveness of using Cerament-G in the treatment of chronic long bone osteomyelitis by comparing this innovative strategy to standard of care. A cost-utility analysis from the collective perspective will be conducted over a 24-month time horizon after the initial surgery. The outcome for the main medico-economic evaluation will be Quality Adjusted Life Years (QALYs).DiscussionThe study is being conducted throughout the CRIOAc network in France, in referral centers for the management of complex infections which will facilitate patient recruitment. This study has several limitations: the investigators have to be trained to handle the device, and it was impossible to blind the surgeon.ConclusionIf the use of Cerament-G is demonstrated to be superior to leaving the dead space empty during surgery for patients with stage III chronic long bone osteomyelitis, its use will be recommended to improve the prognosis of such patients, and this device may eventually qualify for reimbursement through the French Health Insurance scheme.Ethics and disseminationThis protocol received authorization from the Ethics Committee CPP Sud Méditerranée V on April 27, 2021 (21.03.10.77652) and the French National Agency for Medicines and Health Products on May 6, 2021 (2020-A02299-30). Results will be disseminated to the scientific community through congresses and publication in peer-reviewed journals. |
| first_indexed | 2024-04-09T20:38:52Z |
| format | Article |
| id | doaj.art-38dedca22af8413e97b2909544601f40 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-04-09T20:38:52Z |
| publishDate | 2023-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-38dedca22af8413e97b2909544601f402023-03-30T06:02:51ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-03-011010.3389/fmed.2023.11167111116711Cost-effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones: Protocol for the CONVICTION randomized multicenter studyHassan Serrier0Laure Huot1Laure Huot2Sophie Brosset3Sophie Brosset4Cécile Batailler5Cécile Batailler6Cécile Batailler7Tristan Ferry8Tristan Ferry9Tristan Ferry10Tristan Ferry11Health Economic Evaluation Service, Hospices Civils de Lyon, Lyon, FranceHealth Economic Evaluation Service, Hospices Civils de Lyon, Lyon, FranceUniversité Claude Bernard Lyon 1, Research on Healthcare Performance RESHAPE, Lyon, FranceCentre interrégional de référence pour la prise en charge des infections ostéoarticulaires complexes, CRIOAc Lyon, Hospices Civils de Lyon, Lyon, FranceDepartment of Plastic Surgery, Croix-Rousse Hospital, Lyon University Hospital, Lyon, FranceCentre interrégional de référence pour la prise en charge des infections ostéoarticulaires complexes, CRIOAc Lyon, Hospices Civils de Lyon, Lyon, FranceDepartment of Orthopaedic Surgery, Croix-Rousse Hospital, Lyon University Hospital, Lyon, FranceUniv Lyon, Claude Bernard Lyon 1 University, Bron, FranceCentre interrégional de référence pour la prise en charge des infections ostéoarticulaires complexes, CRIOAc Lyon, Hospices Civils de Lyon, Lyon, FranceInfectious Diseases, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, FranceCIRI–Centre International de Recherche en Infectiologie, Inserm, Université́ Claude Bernard Lyon 1, Ecole Normale Supérieure de Lyon, Univ Lyon, Lyon, FranceUniversité Claude Bernard Lyon 1, Lyon, FranceIntroductionChronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones, responsible for significant morbidity with the risk of fracture and amputation. Despite advances in both antibiotics and surgical treatment, the probability of recurrence of infection remains at around 20%. Cerament-G (BONESUPPORT AB, Sweden) is a synthetic bone substitute that fills the bone void left by surgery, prevents infection and promotes bone regeneration within this space. Cerament-G also provides the local delivery of high doses of gentamicin over several weeks. Two prospective observational studies described a number of infectious recurrences of 4 and 5% after the use of Cerament-G. Although available in France, Cerament-G is currently not reimbursed and its high cost constitutes a barrier to its use. We hypothesize that the use of Cerament-G will lead to fewer costs to the collectivity while improving patient utility and, as an innovative strategy, will be superior to standard of care on recurrence of infection.Methods and analysisThe Conviction Study is a prospective, multicenter, randomized, single blind study conducted in 14 French Reference Centers for Complex Osteoarticular infections. The main objective is to evaluate the cost-effectiveness of using Cerament-G in the treatment of chronic long bone osteomyelitis by comparing this innovative strategy to standard of care. A cost-utility analysis from the collective perspective will be conducted over a 24-month time horizon after the initial surgery. The outcome for the main medico-economic evaluation will be Quality Adjusted Life Years (QALYs).DiscussionThe study is being conducted throughout the CRIOAc network in France, in referral centers for the management of complex infections which will facilitate patient recruitment. This study has several limitations: the investigators have to be trained to handle the device, and it was impossible to blind the surgeon.ConclusionIf the use of Cerament-G is demonstrated to be superior to leaving the dead space empty during surgery for patients with stage III chronic long bone osteomyelitis, its use will be recommended to improve the prognosis of such patients, and this device may eventually qualify for reimbursement through the French Health Insurance scheme.Ethics and disseminationThis protocol received authorization from the Ethics Committee CPP Sud Méditerranée V on April 27, 2021 (21.03.10.77652) and the French National Agency for Medicines and Health Products on May 6, 2021 (2020-A02299-30). Results will be disseminated to the scientific community through congresses and publication in peer-reviewed journals.https://www.frontiersin.org/articles/10.3389/fmed.2023.1116711/fullchronic osteomyelitisosteoarticular infectionlocal antibiotic therapybone substituteantibiotic resistancecost-effectiveness |
| spellingShingle | Hassan Serrier Laure Huot Laure Huot Sophie Brosset Sophie Brosset Cécile Batailler Cécile Batailler Cécile Batailler Tristan Ferry Tristan Ferry Tristan Ferry Tristan Ferry Cost-effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones: Protocol for the CONVICTION randomized multicenter study Frontiers in Medicine chronic osteomyelitis osteoarticular infection local antibiotic therapy bone substitute antibiotic resistance cost-effectiveness |
| title | Cost-effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones: Protocol for the CONVICTION randomized multicenter study |
| title_full | Cost-effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones: Protocol for the CONVICTION randomized multicenter study |
| title_fullStr | Cost-effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones: Protocol for the CONVICTION randomized multicenter study |
| title_full_unstemmed | Cost-effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones: Protocol for the CONVICTION randomized multicenter study |
| title_short | Cost-effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones: Protocol for the CONVICTION randomized multicenter study |
| title_sort | cost effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones protocol for the conviction randomized multicenter study |
| topic | chronic osteomyelitis osteoarticular infection local antibiotic therapy bone substitute antibiotic resistance cost-effectiveness |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2023.1116711/full |
| work_keys_str_mv | AT hassanserrier costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT laurehuot costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT laurehuot costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT sophiebrosset costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT sophiebrosset costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT cecilebatailler costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT cecilebatailler costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT cecilebatailler costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT tristanferry costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT tristanferry costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT tristanferry costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy AT tristanferry costeffectivenessofabonesubstitutedeliveringgentamicininthetreatmentofchronicosteomyelitisoflongbonesprotocolfortheconvictionrandomizedmulticenterstudy |