Bone Loss Clinical Trial
Official title:
Treatment of Fracture Related Infection in Latin America. International Multicenter Study
Postoperative bone infection is a severe complication in the treatment of fractures and is more frequent than in elective joint replacement surgeries. Surgical treatment is based on meticulous debridement of bone and soft tissue, dead space management, soft tissue reconstruction when necessary, and restoration of bony stability in the non-union fracture. In addition, local antibiotic therapy is recommended in certain circumstances. This study aims to evaluate the results of surgical treatment of fracture-related infection in Latin America.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2023 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Adult patients (18 years or older) - Infection after surgical fracture treatment occurred 90 days after the initial surgery. - Definitive treatment in one of the centers involved - Hospital admission from January 1, 2018, to December 31, 2020 - Minimum outpatient follow-up period of one year after the main surgery to treat the infection, assess the quality of life, and control of the infection. Exclusion Criteria: - Incomplete medical records |
Country | Name | City | State |
---|---|---|---|
Brazil | Manoel Victorino Hospital | Salvador | Bahia |
Lead Sponsor | Collaborator |
---|---|
Manoel Victorino Hospital | AO Trauma Latin America, Centro Médico Nacional de Occidente IMSS, Hospital Italiano de Buenos Aires, Hospital Municipal Miguel Couto, Hospital Pablo Tobón Uribe, University of Campinas, Brazil |
Brazil,
Alcântara JE JUNIOR, Aguiar RA, Sampaio JGL NETO, Azi ML, Sadigursky D, Alencar DF. FACTORS ASSOCIATED WITH THE DEVELOPMENT OF EARLY INFECTION AFTER SURGICAL TREATMENT OF FRACTURES. Acta Ortop Bras. 2018 Jan-Feb;26(1):22-26. doi: 10.1590/1413-785220182601173883. — View Citation
Bezstarosti H, Van Lieshout EMM, Voskamp LW, Kortram K, Obremskey W, McNally MA, Metsemakers WJ, Verhofstad MHJ. Insights into treatment and outcome of fracture-related infection: a systematic literature review. Arch Orthop Trauma Surg. 2019 Jan;139(1):61-72. doi: 10.1007/s00402-018-3048-0. Epub 2018 Oct 20. — View Citation
Depypere M, Morgenstern M, Kuehl R, Senneville E, Moriarty TF, Obremskey WT, Zimmerli W, Trampuz A, Lagrou K, Metsemakers WJ. Pathogenesis and management of fracture-related infection. Clin Microbiol Infect. 2020 May;26(5):572-578. doi: 10.1016/j.cmi.2019.08.006. Epub 2019 Aug 22. Review. — View Citation
Govaert GAM, Kuehl R, Atkins BL, Trampuz A, Morgenstern M, Obremskey WT, Verhofstad MHJ, McNally MA, Metsemakers WJ; Fracture-Related Infection (FRI) Consensus Group. Diagnosing Fracture-Related Infection: Current Concepts and Recommendations. J Orthop Trauma. 2020 Jan;34(1):8-17. doi: 10.1097/BOT.0000000000001614. — View Citation
Hotchen AJ, McNally MA, Sendi P. The Classification of Long Bone Osteomyelitis: A Systemic Review of the Literature. J Bone Jt Infect. 2017 Sep 12;2(4):167-174. doi: 10.7150/jbji.21050. eCollection 2017. Review. — View Citation
Metsemakers WJ, Fragomen AT, Moriarty TF, Morgenstern M, Egol KA, Zalavras C, Obremskey WT, Raschke M, McNally MA; Fracture-Related Infection (FRI) consensus group. Evidence-Based Recommendations for Local Antimicrobial Strategies and Dead Space Management in Fracture-Related Infection. J Orthop Trauma. 2020 Jan;34(1):18-29. doi: 10.1097/BOT.0000000000001615. Review. — View Citation
Metsemakers WJ, Kuehl R, Moriarty TF, Richards RG, Verhofstad MHJ, Borens O, Kates S, Morgenstern M. Infection after fracture fixation: Current surgical and microbiological concepts. Injury. 2018 Mar;49(3):511-522. doi: 10.1016/j.injury.2016.09.019. Epub 2016 Sep 11. Review. — View Citation
Metsemakers WJ, Morgenstern M, McNally MA, Moriarty TF, McFadyen I, Scarborough M, Athanasou NA, Ochsner PE, Kuehl R, Raschke M, Borens O, Xie Z, Velkes S, Hungerer S, Kates SL, Zalavras C, Giannoudis PV, Richards RG, Verhofstad MHJ. Fracture-related infection: A consensus on definition from an international expert group. Injury. 2018 Mar;49(3):505-510. doi: 10.1016/j.injury.2017.08.040. Epub 2017 Aug 24. — View Citation
Morgenstern M, Moriarty TF, Kuehl R, Richards RG, McNally MA, Verhofstad MHJ, Borens O, Zalavras C, Raschke M, Kates SL, Metsemakers WJ. International survey among orthopaedic trauma surgeons: Lack of a definition of fracture-related infection. Injury. 2018 Mar;49(3):491-496. doi: 10.1016/j.injury.2018.02.001. Epub 2018 Feb 6. — View Citation
Steinmetz S, Wernly D, Moerenhout K, Trampuz A, Borens O. Infection after fracture fixation. EFORT Open Rev. 2019 Jul 15;4(7):468-475. doi: 10.1302/2058-5241.4.180093. eCollection 2019 Jul. Review. — View Citation
Trampuz A, Zimmerli W. Diagnosis and treatment of infections associated with fracture-fixation devices. Injury. 2006 May;37 Suppl 2:S59-66. Review. — View Citation
Walter G, Kemmerer M, Kappler C, Hoffmann R. Treatment algorithms for chronic osteomyelitis. Dtsch Arztebl Int. 2012 Apr;109(14):257-64. doi: 10.3238/arztebl.2012.0257. Epub 2012 Apr 6. Review. — View Citation
Zimmerli W, Sendi P. Orthopaedic biofilm infections. APMIS. 2017 Apr;125(4):353-364. doi: 10.1111/apm.12687. Review. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Usefulness of the FRI diagnosing criteria | To analyze the usefulness of the criteria proposed by the expert consensus for diagnosing fractures-related infections. | at least 6 months after infection treatment | |
Secondary | Surgical treatment | Describe the strategies of surgical treatment in patients with infections related to fractures | at least 12 months after infection treatment | |
Secondary | Microbiological profile | Describe the microbiological profile of fracture-related infections in Latin American centers. | just after infection treatment | |
Secondary | Variables associated with outcomes | To explore variables associated with the outcome of fracture-related infection control | at least 12 months after infection treatment | |
Secondary | Strategies for the management of soft tissue defects | Describe the strategies for the management of soft tissue defects associated with infections related to fractures. | at least 6 months after infection treatment | |
Secondary | Quality of life - EQ-5D-3L | Describe the results in terms of the quality of life of patients with infections related to fractures | at least 12 months after infection treatment |
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