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

NCT ID: NCT03459261

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2014-01-31

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.

Conditions

Osteomyelitis Tibia; Surgical Site Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: 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).

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.

No interventions assigned to this group

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Alojz Ihan, MD, Ph.D, Institute of Microbiology and Immunology, Ljubljana, Slovenia

UNKNOWN

Sponsor Role: collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Matjaž Groznik, MD

Head of HDU at Traumatology Department Matjaž Groznik, MD, Specialist in Traumatology and Intensive Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20120130

Identifier Type: -

Identifier Source: org_study_id