FractureNCT05467644
Treatment of Fracture Related Infection in Latin America.
An observational study of Fracture and Osteomyelitis, run by Manoel Victorino Hospital at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Fracture, Osteomyelitis, Soft Tissue Injuries
- What is being tested?
- Treatment of Fracture Related Infection
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients diagnosed with Fracture-related Infection
Who may be able to join
- 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.
Who cannot join
- Incomplete medical records
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Manoel Victorino Hospital
Salvador, Estado de Bahia, 40301155
Nilma Caldas, +557132541250, residenciamedicahmv@gmail.com
Matheus Azi, PhD, +557132541250, matheus.azi@saude.ba.gov.br
About this study
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.
Read the detailed description
Research question: What are the characteristics and the diagnostic and therapeutic approach of patients with fracture-related infections (FRI) managed in various centers in Latin America?
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
- Fracture, Osteomyelitis, Soft Tissue Injuries, Bone Loss
- Being tested
- Treatment of Fracture Related Infection
- Keywords
- Fracture, Osteomyelitis, Soft Tissue Injuries, Bone Loss
- Medical subject headings
- Fractures, Bone, Osteomyelitis, Soft Tissue Injuries, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of Fracture Related InfectionProcedure or surgery
Observational Retrospective Study. Only one group. Patients diagnosed with fracture-related infection and submitted to surgical treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Usefulness of the FRI diagnosing criteria
To analyze the usefulness of the criteria proposed by the expert consensus for diagnosing fractures-related infections.
Measured: at least 6 months after infection treatment
Secondary outcomes (5)
Surgical treatment
Describe the strategies of surgical treatment in patients with infections related to fractures
Measured: at least 12 months after infection treatment
Microbiological profile
Describe the microbiological profile of fracture-related infections in Latin American centers.
Measured: just after infection treatment
Variables associated with outcomes
To explore variables associated with the outcome of fracture-related infection control
Measured: at least 12 months after infection treatment
Strategies for the management of soft tissue defects
Describe the strategies for the management of soft tissue defects associated with infections related to fractures.
Measured: at least 6 months after infection treatment
Quality of life - EQ-5D-3L
Describe the results in terms of the quality of life of patients with infections related to fractures
Measured: at least 12 months after infection treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jan 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manoel Victorino Hospital
- Sponsor type
- Other government
- Collaborators
- AO Trauma Latin America, Centro Médico Nacional de Occidente IMSS, University of Campinas, Brazil, Hospital Municipal Miguel Couto, Hospital Italiano de Buenos Aires, Hospital Pablo Tobón Uribe
- Responsible party
- Principal investigator, Matheus Lemos Azi, Manoel Victorino Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467644
- Sponsor's protocol ID
- FRI LATIN AMERICA - AOLAT
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Six countries are involved in the study, and they have different regulations regarding handling patient data. Therefore, researchers will assess data sharing during the data analysis phase of the study.
Publications
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.
PubMed 22536302Trampuz 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.
PubMed 16651073Steinmetz 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.
PubMed 31423330Alcantara 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.
PubMed 29977139Metsemakers 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.
PubMed 28867644Depypere 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.
PubMed 31446152Zimmerli W, Sendi P. Orthopaedic biofilm infections. APMIS. 2017 Apr;125(4):353-364. doi: 10.1111/apm.12687.
PubMed 28407423Hotchen 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.
PubMed 29119075Morgenstern 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.
PubMed 29433799Metsemakers 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.
PubMed 27639601Bezstarosti 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.
PubMed 30343322Govaert 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.
PubMed 31855973Metsemakers 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.
PubMed 31464858
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Fracture Related Infection in Latin America. International Multicenter Study
- ClinicalTrials.gov ID
- NCT05467644
- Acronym / sponsor ID
- FRI LATIN AMERICA - AOLAT
- Conditions
- Fracture, Osteomyelitis, Soft Tissue Injuries, Bone Loss
- Keywords
- Fracture, Osteomyelitis, Soft Tissue Injuries, Bone Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Manoel Victorino HospitalOther government
- Collaborators
- AO Trauma Latin America, Centro Médico Nacional de Occidente IMSS, University of Campinas, Brazil, Hospital Municipal Miguel Couto, Hospital Italiano de Buenos Aires, Hospital Pablo Tobón Uribe
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jul 2022 (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.
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.
Detailed description
Research question: What are the characteristics and the diagnostic and therapeutic approach of patients with fracture-related infections (FRI) managed in various centers in Latin America?
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with Fracture-related Infection
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Incomplete medical records
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 |
|---|---|---|
| Treatment of Fracture Related InfectionObservational Retrospective Study. Only one group. Patients diagnosed with fracture-related infection and submitted to surgical treatment | Procedure or surgery | – |
Primary outcome
Usefulness of the FRI diagnosing criteria
Time frame: at least 6 months after infection treatment
To analyze the usefulness of the criteria proposed by the expert consensus for diagnosing fractures-related infections.
5 secondary outcomes
Surgical treatment
Time frame: at least 12 months after infection treatment
Microbiological profile
Time frame: just after infection treatment
Variables associated with outcomes
Time frame: at least 12 months after infection treatment
Strategies for the management of soft tissue defects
Time frame: at least 6 months after infection treatment
Quality of life - EQ-5D-3L
Time frame: at least 12 months after infection treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 22536302Walter 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.
- Background: PubMed 16651073Trampuz 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.
- Background: PubMed 31423330Steinmetz 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.
- Background: PubMed 29977139Alcantara 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.
- Background: PubMed 28867644Metsemakers 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.
- Background: PubMed 31446152Depypere 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.
- Background: PubMed 28407423Zimmerli W, Sendi P. Orthopaedic biofilm infections. APMIS. 2017 Apr;125(4):353-364. doi: 10.1111/apm.12687.
- Background: PubMed 29119075Hotchen 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.
- Background: PubMed 29433799Morgenstern 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.
- Background: PubMed 27639601Metsemakers 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.
- Background: PubMed 30343322Bezstarosti 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.
- Background: PubMed 31855973Govaert 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.
- Individual participant dataSharing planned: Undecided. Six countries are involved in the study, and they have different regulations regarding handling patient data. Therefore, researchers will assess data sharing during the data analysis phase of the study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture and Osteomyelitis, run by Manoel Victorino Hospital at 1 site in Brazil.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matheus Azi, PhD (+557132541250, matheus.azi@saude.ba.gov.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usefulness of the FRI diagnosing criteria (time frame: at least 6 months after infection treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05467644, which also lists 13 linked publications.
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 20 Jul 2022.