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

University Medical Centre Ljubljana

Status: Completed

Conditions: Surgical Site Infection; Osteomyelitis Tibia

Treatments: Diagnostic Test: blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)

Study type: Observational

Funder types: Other

Identifiers

NCT03459261

20120130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

86 participants in 2 patient groups

POM

Description:

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.

Treatment:

Diagnostic Test: blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)

NO POM

Description:

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.