Intramedullary Nailing Versus External Fixation in Open Tibia Fractures in Tanzania

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 es Salaam, Tanzania. The investigators hope to determine the optimal management of severe open tibial fractures in Sub-Saharan Africa in order to reduce long-term disability, limit the economic impact of injury, and avoid resource costs of reoperation. The investigators plan to compare the all-cause reoperation rate for AO/Orthopaedic Trauma Association (OTA) Type 42 open tibial shaft fractures treated with initial intramedullary nailing versus external fixation at Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania, to compare rates of secondary clinical endpoints including postoperative superficial and deep infection, clinical union, radiographic union, malunion, and health-related quality of life with minimum one year follow-up, and identify prognostic factors related to the patient, injury, or management protocol that impact the reoperation rate, return to work, and health-related quality of life.

Conditions

• Tibial Fractures
• Open Fracture of Tibia
• Trauma

Interventions

PROCEDURE

Intramedullary nailing with standard SIGN nail

Patients meeting eligibility requirements are randomized to either study arm. Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures using the standard SIGN nail (SIGN Fracture Care International, Richland, WA). The number of interlocking screws is at the discretion of the treating surgeon, who also has the option to use an external fixator for damage control, and later conversion to IMN when clinically appropriate. The experimental group procedure is less common in the study setting, and thus, viewed as the experimental group.

PROCEDURE

External Fixation with uniplanar Dispofix external fixator

Patients meeting eligibility requirements are randomized to either study arm. Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures using the uniplanar Dispofix external fixator with two Shanz screws placed proximally and two Schanz screws placed distally to fracture site with a single stainless steel bar.The active comparator group procedure is more common in the study setting, and thus, viewed as the comparator group.

Sponsors & Collaborators

• Wyss Foundation, Inc

  collaborator UNKNOWN

• Doris Duke Charitable Foundation

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Saam Morshed, MD, MPH · University of California, San Francisco

• David Shearer, MD, MPH · University of California, San Francisco

• Billy Haonga, MD · Muhimbili Orthopaedic Institute

• Edmund Eliezer, MD · Muhimbili Orthopaedic Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-17

Primary Completion

2017-03-25

Completion

2017-03-25