N/A
Completed N=260
MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants
Open Reduction and Internal Fixation of Extremity Fractures
Source: ClinicalTrials.gov NCT03132246 ↗
Enrolled (actual)
260
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum) — 48; 53 blood draw samples
Summary
A prospective trial conducted at Shock Trauma of patients between 18 years of age and older who have sustained a fracture with metal implanted. The investigators will be collecting between 1-3 routine blood draws for the purpose of laboratory analysis to assess biofilm growth. Patients may be infected or non-infected at the time of blood draw; they will be selected at random for purposes of this study. All patients will be followed as standard of care by their treating physician for all their follow up visits.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum) |
48; 53 | — |
| SECONDARY Number of Blood Samples With Low Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum) |
4; 92 | — |
Eligibility Criteria
Inclusion Criteria
- Previous fracture fixation with an implant (intramedullary nail, plate, screws), or joint revisions, or periprosthetic fracture, or admitted from orthopaedic trauma clinic due to infection, or inpatient with a known infection.
- English speaking
Exclusion Criteria
- Patients with planned follow-up at another medical center
- Patient lives outside of the hospital catchment area
Data sourced from ClinicalTrials.gov (NCT03132246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.