Treatment of Fracture Related Infection in Latin America.
NCT ID: NCT05467644
Last Updated: 2022-07-20
Study Results
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Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2021-01-01
2023-12-31
Brief Summary
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Detailed Description
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Objectives:
General objective Describe the treatment of FRI in different institutions in Latin America, emphasizing the diagnostic process and the surgical and medical approach to this type of patient.
Specific objectives:
To analyze the usefulness of the criteria proposed by the expert consensus for diagnosing FRI.
Describe surgical treatment strategies in patients with FRI. Describe the microbiological profile of FRI in Latin American centers To explore variables associated with outcomes. Describe strategies for managing soft tissue defects associated with FRI. Describe the results regarding patients' quality of life with FRI.
Methodology:
Type of study: Observational retrospective cohort study
Outcomes to evaluate:
Infectious relapse: Presence of confirmatory or suggestive clinical signs of infection related to fractures, according to the FRI consensus criteria, within the first year of follow-up after the main surgery for the treatment of infection, and that motivates an intervention additional (Surgery or additional antibiotics) Consolidation: defined as clinical and radiological consolidation. Clinical consolidation - the absence of pain on local palpation and with load or walking. Radiological consolidation - Presence of bone trabeculae in the fracture line in the four cortices of the two standard radiological projections.
Complications: Defined as any adverse event that requires surgery for treatment. It can be "immediate" (those requiring an additional surgical procedure within up to 30 days of treatment of the infection. Examples: hematoma, debridement, change of fixators, change of implant, even if partial) or "late" ( those that required surgical procedure after 30 days of definitive treatment (for example debridement, implant failure, bone grafting).
Proposed statistical analysis: Descriptive statistics tools will be used for qualitative variables, absolute and relative frequencies, quantitative variables, measures of central tendency such as mean or median, and measures of dispersion such as standard deviation or interquartile range, according to the distribution of the variables. Univariate analyses will be performed to explore the relationship of different variables with the risk of infectious relapse, treatment failure, and amputation. All statistical analyzes will be executed in SPSS Statistics® v20 (IBM, Chicago, IL).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Treatment of Fracture Related Infection
Observational Retrospective Study. Only one group. Patients diagnosed with fracture-related infection and submitted to surgical treatment
Eligibility Criteria
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Inclusion Criteria
* 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
16 Years
ALL
No
Sponsors
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AO Trauma Latin America
UNKNOWN
Centro Médico Nacional de Occidente IMSS
UNKNOWN
University of Campinas, Brazil
OTHER
Hospital Municipal Miguel Couto
OTHER
Hospital Italiano de Buenos Aires
OTHER
Hospital Pablo Tobón Uribe
OTHER
Manoel Victorino Hospital
OTHER_GOV
Responsible Party
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Matheus Lemos Azi
Principal Investigator
Locations
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Manoel Victorino Hospital
Salvador, Estado de Bahia, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Trampuz A, Zimmerli W. Diagnosis and treatment of infections associated with fracture-fixation devices. Injury. 2006 May;37 Suppl 2:S59-66. doi: 10.1016/j.injury.2006.04.010.
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.
Alcantara 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.
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.
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.
Zimmerli W, Sendi P. Orthopaedic biofilm infections. APMIS. 2017 Apr;125(4):353-364. doi: 10.1111/apm.12687.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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FRI LATIN AMERICA - AOLAT
Identifier Type: -
Identifier Source: org_study_id
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