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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202007730039055

Enrollment

Registered

2020-07-08

Start date

2016-04-05

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopaedics

Interventions

Unmreamed intramedullary nail

External Fixation

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Function IndeX for Trauma (FIX-IT) score	—

Secondary

Measure	Time frame
Euro-Qol 5-D ;Radiographic healing;Malunion;Nonunion;Reoperation;Infection;Wound healing	—

Countries

Uganda

Contacts

Public ContactNathan OHara

Research Associate University of Maryland

nohara@som.umaryland.edu+14103289579

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026