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Clinical Trials/PACTR202007730039055
PACTR202007730039055
Completed
Phase 3

Clinical Outcomes for Open Tibial Shaft Fractures: A Prospective Randomized Trial Comparing External Fixation to Unreamed Intramedullary Nailing in Uganda

AO Alliance Foundation0 sites50 target enrollmentJune 25, 2020
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ConditionsOrthopaedics

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Orthopaedics
Sponsor
AO Alliance Foundation
Enrollment
50
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 25, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
AO Alliance Foundation

Eligibility Criteria

Inclusion Criteria

  • •Skeletally mature
  • •Isolated Type II/IIIA open fracture of the tibial shaft with complete anteroposterior (AP) and lateral radiographs
  • •Operative treatment within 24hrs of injury.
  • •Provision of Informed Consent by the patient

Exclusion Criteria

  • •Tibial fracture is not amenable to unreamed intramedullary nailing
  • •Fracture extends \<5cm distal to tibial tubercle or \<5cm proximal to tibiotalar joint
  • •Pathologic fracture
  • •Pre\-existing infection
  • •Other significant injuries like severe head trauma or polytrauma.
  • •Fracture with significant soft tissue defect requiring flap, or vascular compromise

Outcomes

Primary Outcomes

Not specified

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