Clinical trial NCT03459261: Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures and Biomarkers
Official title: Can we Improve the Treatment of Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures by Using Perioperative Immunoinflammatory Markers?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteomyelitis Tibia
Surgical Site Infection
Keywords: osteomyelitis
tibial fracture
cytokines
PCT
CRP
albumin
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Prof. Alojz Ihan, MD, Ph.D, Institute of Microbiology and Immunology, Ljubljana, Slovenia
First posted: 2018-03-08
Enrollment: 86
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Measurement of biomarkers CRP, PCT, WBC on ADD, POD1, POD4
timeFrame: perioperative period
measure: Assessment of patients' immune status
timeFrame: perioperative period
measure: Determination of cytokines level in serum: tumor necrosis factor (TFN-alpha), interleukin-6 (IL-6), interleukin-10 (IL-1) and lymphocyte populations
timeFrame: perioperative period
Secondary outcomes:
Other outcomes:
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