Infection Rate With Intramedullary Interlocking Nail Versus Plate Fixation in Open Tibial Fractures
Infection Rate of ILN vs Plate in Open Fracture Tibia Treated With Prophylactic Antibiotic
Open fractures of the tibia are at risk of infection because the injury damages the surrounding soft tissues. This study will compare the frequency of postoperative infection in patients with Gustilo-Anderson type I and II open tibial shaft fractures treated with intramedullary interlocking nail (ILN) fixation or plate fixation after three days of intravenous prophylactic antibiotic therapy.
A total of 170 patients aged 18-60 years will be included and randomly allocated into two groups of 85 patients each. Group A will undergo ILN fixation, while Group B will undergo plate fixation. Patients will be monitored for signs of infection, including pain, redness, swelling, and wound discharge, during hospital stay and follow-up. The main outcome will be the presence of postoperative infection within three months of surgery.
The findings may help clinicians compare infection rates between these two fixation methods in open tibial shaft fractures.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Asif Asif Khan, post graduate trainee orthopa
- Phone Number: +923012996395
- Email: wazirkhancr768@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
Inclusion Criteria
- Patients aged 18-60 years.
- Both genders.
- Gustilo-Anderson type I and II open tibial shaft fractures.
- Patients receiving three days of intravenous antibiotic therapy prior to definitive fixation.
Exclusion Criteria:
-
• Gustilo-Anderson type III fractures.
- Pathological fractures.
- Polytrauma patients.
- Patients with diabetes mellitus, immunosuppression, or peripheral vascular disease.
- Previous surgery on the affected limb
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1Intramedullary Interlocking Nail Fixation
Patients will undergo surgical fixation of open tibial fractures using an intramedullary interlocking nail. |
Surgical fixation of open tibial fractures using an intramedullary interlocking nail. |
|
Active Comparator: Arm 2 Plate Fixation
Patients will undergo surgical fixation of open tibial fractures using plate fixation. |
Surgical fixation of open tibial fractures using plate and screw fixation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of Postoperative Infection
Time Frame: Within 3 months after surgery
|
Postoperative infection will be assessed by the presence of clinical signs of infection, including pain, redness, swelling, and wound discharge, with or without a positive wound culture. Infection rates will be compared between patients treated with intramedullary interlocking nail fixation and plate fixation. |
Within 3 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Score
Time Frame: Third postoperative day
|
Postoperative pain will be assessed using the Visual Analog Scale (VAS) and compared between the two treatment groups. |
Third postoperative day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 48.ERC/FMU/2025-26/366
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared with other researchers. The data will be kept confidential and used only for the purposes of this research study. Access to study data will be restricted to authorized members of the research team.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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