Osteomyelitis TibiaPOMTIBIALNCT03459261
Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures and Biomarkers
An observational study of Osteomyelitis Tibia and Surgical Site Infection, run by University Medical Centre Ljubljana.
Trial summary
The present trial was aimed to identify which biomarkers could be associated in perioperative period after surgical treatment of tibial fracture to the development of POM. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Osteomyelitis Tibia, Surgical Site Infection
- What is being tested?
- blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Jan 2014
- How long will I take part?
- 6 Months
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to the Department of Traumatology at University Clinical Centre Ljubljana were included after written informed consent.
Who may be able to join
- high-energy injury to proximal, shaft or distal tibia,
- tibial fracture requiring primary surgical treatment /ORIF
Who cannot join
- ankle fracture,
- patella fracture,
- avulsion fracture of the knee,
- malignant neoplasm and pathological tibial fracture,
- systemic autoimmune disease of connective tissue,
- immature patients under 15 years of age (children),
- immunocompromised patients.
About this study
Official title: Can we Improve the Treatment of Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures by Using Perioperative Immunoinflammatory Markers?
The present trial was aimed to identify which biomarkers could be associated in perioperative period after surgical treatment of tibial fracture to the development of POM.
Read the detailed description
Early diagnosis of acute posttraumatic osteomyelitis (POM) is of vital importance for avoiding devastating complications. Diagnosing POM is difficult due to the lack of a highly specific and sensitive test, such as in myocardial infarct, stroke and intracranial bleeding. Serum inflammatory markers, C-reactive protein (CRP), procalcitonin (PCT), white blood cells (WBC) can support clinical findings but they are not able to differentiate between inflammatory response to infection and the host response to non-infection insult with high specificity and sensitivity.
The prospective nonrandomised cohort study included 86 patients after high-energy injury to the shin requiring primary surgical treatment (open or closed reduction and internal fixation of tibial fracture). Values of the biochemical and immunoinflammatory profile were measured on admission (ADD), first postoperative day (POD1) and fourth-postoperative day (POD4).
The objectives of the study were to investigate that the biochemical and immunoinflammatory profile could facilitate postoperative monitoring, guide the antibiotic treatment and timing of revision surgery.
- Conditions
- Osteomyelitis Tibia, Surgical Site Infection
- Being tested
- blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)
- Keywords
- osteomyelitis, tibial fracture, cytokines, PCT, CRP, albumin
- Medical subject headings
- Surgical Wound Infection, Osteomyelitis, Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)Diagnostic test
Laboratory analyses of peripheral venous blood on admission (blood sample ADD), 24 hours after surgery (blood sample POD1) and fourth-day after surgery (blood sample POD4) included biochemical analysis, complete blood count, C-reactive protein (CPR), procalcitonin (PCT), albumin/protein level, prothrombin time and international normalized ratio (INR) (only on admission) and for determination of cytokines: tumor necrosis factor alpha (TFN-α), interleukin-6 (IL-6), interleukin-10 (IL-10).
| Study group | Role | What they receive |
|---|---|---|
| POM | post-traumatic osteomyelitis group (POM), the participants who developed post-traumatic osteomyelitis after primary surgical treatment and were taken blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4). Patients were included in POM group after additional assessment of meeting the CDC/NHSN surveillance definition criteria for osteomyelitis: positive intraoperative withdrawal bone and soft tissue sample, types of cultured bacteria, histopathologic proof of osteomyelitis and clinical signs of surgical site infection. Receives: Diagnostic Test: blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4) | |
| NO POM | No POM group, the participants who did not develop postraumatic osteomyelitis to tibia after primary surgical treatment and were taken blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4) in follow up interval of 6 months /control group/. Patients were included in No POM group after assessment of not meeting the CDC/NHSN surveillance definition criteria for osteomyelitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of biomarkers CRP, PCT, WBC on ADD, POD1, POD4
WBC count (reference range 4-10 x 109/L), WBC differential (neutrophil count 1.50-7.40 x 109/L, lymphocyte count 1.10-3.50 x 109/L) and hematocrit (reference range 0.390-0.500) were analyzed with a hematological blood analyzer LH75 (Beckman Coulter). The immunocytochemic analyzer Modular Analytics SWE (Roche Diagnostics) was used for serum samples analysis. The serum concentration of CRP (reference range 0-5mg/L) was measured by the immunoturbidimetric method, PCT (reference range 0-0.5μg/L) by the electrochemiluminescence method and albumins (reference range 35-52g/L) by the bromcresol green method.
Measured: perioperative period
Assessment of patients' immune status
Whole venous blood was collected into vacutainer tubes containing EDTA. Samples were processed for flow cytometry. For surface staining, the standard whole-blood staining methodology as prescribed by the manufacturer (BDBiosciences) was used. For detecting regulatory T cells, samples were stained for surface antigens with a mix of anti-CD25-PE/ anti-CD127-APC/ anti-CD4-PE-Cy™7. All antibodies were obtained from BDBiosciences (Mountain View, Ca, USA). Cells were analyzed on FACSCantoII™ Flow Cytometer (BDBiosciences) equipped with blue (488-nm solid-state) and red (633-nm helium-neon) laser. Digital data was acquired with FACSDiva software (BDBiosciences) and analyzed using FlowJo software (Tree Star Inc.,).
Measured: perioperative period
Determination of cytokines level in serum: tumor necrosis factor (TFN-alpha), interleukin-6 (IL-6), interleukin-10 (IL-1) and lymphocyte populations
Cytokine concentrations were measured by commercially available enzyme-linked immunosorbent assay (ELISA) kits. TNF-α (Milenia Biotec, Germany), IL-6 and IL-10 (Thermo Scientific, USA) were measured according to the manufacturer's instructions.
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Jan 2011
- Primary completion31 Dec 2013
- Study completion31 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis TibiaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 86 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Alojz Ihan, MD, Ph.D, Institute of Microbiology and Immunology, Ljubljana, Slovenia
- Responsible party
- Principal investigator, Matjaž Groznik, MD, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459261
- Sponsor's protocol ID
- 20120130
- Acronym
- POMTIBIAL
- Status last verified
- Mar 2018
- First submitted
- 10 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Improve the Treatment of Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures by Using Perioperative Immunoinflammatory Markers?
- ClinicalTrials.gov ID
- NCT03459261
- Acronym / sponsor ID
- POMTIBIAL / 20120130
- Conditions
- Osteomyelitis Tibia, Surgical Site Infection
- Keywords
- osteomyelitis, tibial fracture, cytokines, PCT, CRP, albumin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Prof. Alojz Ihan, MD, Ph.D, Institute of Microbiology and Immunology, Ljubljana, Slovenia
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Jan 2014 (actual)
- First posted
- 8 Mar 2018 (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.
The present trial was aimed to identify which biomarkers could be associated in perioperative period after surgical treatment of tibial fracture to the development of POM.
Detailed description
Early diagnosis of acute posttraumatic osteomyelitis (POM) is of vital importance for avoiding devastating complications. Diagnosing POM is difficult due to the lack of a highly specific and sensitive test, such as in myocardial infarct, stroke and intracranial bleeding. Serum inflammatory markers, C-reactive protein (CRP), procalcitonin (PCT), white blood cells (WBC) can support clinical findings but they are not able to differentiate between inflammatory response to infection and the host response to non-infection insult with high specificity and sensitivity.
The prospective nonrandomised cohort study included 86 patients after high-energy injury to the shin requiring primary surgical treatment (open or closed reduction and internal fixation of tibial fracture). Values of the biochemical and immunoinflammatory profile were measured on admission (ADD), first postoperative day (POD1) and fourth-postoperative day (POD4).
The objectives of the study were to investigate that the biochemical and immunoinflammatory profile could facilitate postoperative monitoring, guide the antibiotic treatment and timing of revision surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POM | – | Diagnostic Test: blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)post-traumatic osteomyelitis group (POM), the participants who developed post-traumatic osteomyelitis after primary surgical treatment and were taken blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4). Patients were included in POM group after additional assessment of meeting the CDC/NHSN surveillance definition criteria for osteomyelitis: positive intraoperative withdrawal bone and soft tissue sample, types of cultured bacteria, histopathologic proof of osteomyelitis and clinical signs of surgical site infection. |
| NO POM | – | –No POM group, the participants who did not develop postraumatic osteomyelitis to tibia after primary surgical treatment and were taken blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4) in follow up interval of 6 months /control group/. Patients were included in No POM group after assessment of not meeting the CDC/NHSN surveillance definition criteria for osteomyelitis. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to the Department of Traumatology at University Clinical Centre Ljubljana were included after written informed consent.
Key inclusion criteria (2 listed)
- high-energy injury to proximal, shaft or distal tibia,
- tibial fracture requiring primary surgical treatment /ORIF
Key exclusion criteria (7 listed)
- ankle fracture,
- patella fracture,
- avulsion fracture of the knee,
- malignant neoplasm and pathological tibial fracture,
- systemic autoimmune disease of connective tissue,
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 |
|---|---|---|
| blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)Laboratory analyses of peripheral venous blood on admission (blood sample ADD), 24 hours after surgery (blood sample POD1) and fourth-day after surgery (blood sample POD4) included biochemical analysis, complete blood count, C-reactive protein (CPR), procalcitonin (PCT), albumin/protein level, prothrombin time and international normalized ratio (INR) (only on admission) and for determination of cytokines: tumor necrosis factor alpha (TFN-α), interleukin-6 (IL-6), interleukin-10 (IL-10). | Diagnostic test | POM |
Primary outcome
Measurement of biomarkers CRP, PCT, WBC on ADD, POD1, POD4
Time frame: perioperative period
WBC count (reference range 4-10 x 109/L), WBC differential (neutrophil count 1.50-7.40 x 109/L, lymphocyte count 1.10-3.50 x 109/L) and hematocrit (reference range 0.390-0.500) were analyzed with a hematological blood analyzer LH75 (Beckman Coulter). The immunocytochemic analyzer Modular Analytics SWE (Roche Diagnostics) was used for serum samples analysis. The serum concentration of CRP (reference range 0-5mg/L) was measured by the immunoturbidimetric method, PCT (reference range 0-0.5μg/L) by the electrochemiluminescence method and albumins (reference range 35-52g/L) by the bromcresol green method.
Assessment of patients' immune status
Time frame: perioperative period
Whole venous blood was collected into vacutainer tubes containing EDTA. Samples were processed for flow cytometry. For surface staining, the standard whole-blood staining methodology as prescribed by the manufacturer (BDBiosciences) was used. For detecting regulatory T cells, samples were stained for surface antigens with a mix of anti-CD25-PE/ anti-CD127-APC/ anti-CD4-PE-Cy™7. All antibodies were obtained from BDBiosciences (Mountain View, Ca, USA). Cells were analyzed on FACSCantoII™ Flow Cytometer (BDBiosciences) equipped with blue (488-nm solid-state) and red (633-nm helium-neon) laser. Digital data was acquired with FACSDiva software (BDBiosciences) and analyzed using FlowJo software (Tree Star Inc.,).
Determination of cytokines level in serum: tumor necrosis factor (TFN-alpha), interleukin-6 (IL-6), interleukin-10 (IL-1) and lymphocyte populations
Time frame: perioperative period
Cytokine concentrations were measured by commercially available enzyme-linked immunosorbent assay (ELISA) kits. TNF-α (Milenia Biotec, Germany), IL-6 and IL-10 (Thermo Scientific, USA) were measured according to the manufacturer's instructions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis Tibia and Surgical Site Infection, run by University Medical Centre Ljubljana.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of biomarkers CRP, PCT, WBC on ADD, POD1, POD4 (time frame: perioperative period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2018.