Status:
COMPLETED
Intramedullary Nailing Versus External Fixation in Open Tibia Fractures in Tanzania
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Wyss Foundation, Inc
Doris Duke Charitable Foundation
Conditions:
Tibial Fractures
Open Fracture of Tibia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators propose to undertake a randomized, controlled trial which will generate Level 1 evidence concerning optimal fixation methods for the treatment of severe open tibia fractures in Dar e...
Detailed Description
The investigators conducted a prospective randomised controlled trial at a tertiary referral hospital in Dar es Salaam, Tanzania from December 17th, 2015 to March 25th, 2017. All open tibia fractures ...
Eligibility Criteria
Inclusion
- Skeletal maturity
- AO/OTA 42 open tibia fractures
- Wound primarily closeable (no flap or delay in closure due to contamination needed)
- Palpable pedal pulses (no vascular injury sustained)
- Presentation within 24 hours from injury
Exclusion
- Current injury is a pathologic fracture
- Sustained bilateral tibia fracture
- Sustained comminuted femur fracture
- Sustained severe Traumatic Brain Injury (GCS\<12) \*\*\*
- Sustained severe spinal cord injury (lower extremity paresis/paralysis)
- Sustained severe burns (\>10% total body surface area (TBSA) or \>5% TBSA with full thickness or circumferential injury)
- Prior ipsilateral leg injury requiring surgery
- Prior or current lower limb deformity or abnormality
- Unable to complete follow-up visits
Key Trial Info
Start Date :
December 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2017
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03861624
Start Date
December 17 2015
End Date
March 25 2017
Last Update
July 28 2022
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