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Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures and Biomarkers (POMTIBIAL)

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ClinicalTrials.gov Identifier: NCT03459261
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Prof. Alojz Ihan, MD, Ph.D, Institute of Microbiology and Immunology, Ljubljana, Slovenia
Information provided by (Responsible Party):
Matjaž Groznik, MD, University Medical Centre Ljubljana

Brief 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.

Condition or disease Intervention/treatment
Osteomyelitis Tibia Surgical Site Infection Diagnostic Test: blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Can we Improve the Treatment of Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures by Using Perioperative Immunoinflammatory Markers?
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : January 31, 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Diagnostic Test: 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).

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.



Primary Outcome Measures :
  1. 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.

  2. 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.,).

  3. 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.



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the Department of Traumatology at University Clinical Centre Ljubljana were included after written informed consent.
Criteria

Inclusion Criteria:

  • high-energy injury to proximal, shaft or distal tibia,
  • tibial fracture requiring primary surgical treatment /ORIF

Exclusion Criteria:

  • 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.

Additional Information:

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Responsible Party: Matjaž Groznik, MD, Head of HDU at Traumatology Department Matjaž Groznik, MD, Specialist in Traumatology and Intensive Care Medicine, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03459261     History of Changes
Other Study ID Numbers: 20120130
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matjaž Groznik, MD, University Medical Centre Ljubljana:
osteomyelitis
tibial fracture
cytokines
PCT
CRP
albumin

Additional relevant MeSH terms:
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Surgical Wound Infection
Osteomyelitis
Tibial Fractures
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
Leg Injuries