Intramedullary Nailing Versus External Fixation in Open Tibia Fractures in Tanzania

NCT03861624 | Completed DMC

• 1 other identifier: 14-14792
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

Tibia; Intramedullary nailing; External fixation; Trauma

Outcome Measures

Primary Outcomes (1)

• Rate of composite, all-cause reoperation

  The use of composite outcomes has been validated in a wide range of clinical trials. Primary events included in the composite outcome include: infection or hematoma, bone grafting, implant conversion or exchange \>6 weeks after index procedure, implant removal, dynamization of intramedullary nail, osteotomy, amputation.

  One year of definitive skeletal stabilization

Secondary Outcomes (12)

• Rate of superficial infection

  Assessed at clinical follow-up appointments at 2, 6, 12, 26, and 52 weeks

• Rate of deep infection

  Assessed at clinical follow-up appointments at 2, 6, 12, 26, and 52 weeks

• Number of participants with clinical nonunion

  Assessed at clinical follow-up appointments at 6, 12, 26, and 52 weeks

• Number of participants with radiographic nonunion

  Assessed at clinical follow-up appointments at 6, 12, 26, and 52 weeks

• Number of participants with malunion

  Assessed at clinical follow-up appointments at 6, 12, 26, and 52 weeks

Study Arms (2)

Intramedullary nailing

EXPERIMENTAL

Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures via Intramedullary nailing with standard SIGN nail.

Procedure: Intramedullary nailing with standard SIGN nail

External Fixation

ACTIVE COMPARATOR

Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures External Fixation with uniplanar Dispofix external fixator.

Procedure: External Fixation with uniplanar Dispofix external fixator

Interventions

Intramedullary nailing with standard SIGN nail PROCEDURE

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.

Intramedullary nailing

External Fixation with uniplanar Dispofix external fixator PROCEDURE

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.

External Fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Wyss Foundation, Inc: collaborator
• Doris Duke Charitable Foundation: collaborator

Related Publications (16)

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  PMID: 11575908 BACKGROUND

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  PMID: 18685912 BACKGROUND

• Shah RK, Moehring HD, Singh RP, Dhakal A. Surgical Implant Generation Network (SIGN) intramedullary nailing of open fractures of the tibia. Int Orthop. 2004 Jun;28(3):163-6. doi: 10.1007/s00264-003-0535-9. Epub 2004 Jan 9.

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  BACKGROUND

• Ikpeme I, Ngim N, Udosen A, Onuba O, Enembe O, Bello S. External jig-aided intramedullary interlocking nailing of diaphyseal fractures: experience from a tropical developing centre. Int Orthop. 2011 Jan;35(1):107-11. doi: 10.1007/s00264-009-0949-0. Epub 2010 Feb 11.

  PMID: 20148329 BACKGROUND

• Ogunlusi JD, St Rose RS, Davids T. Interlocking nailing without imaging: the challenges of locating distal slots and how to overcome them in SIGN intramedullary nailing. Int Orthop. 2010 Aug;34(6):891-5. doi: 10.1007/s00264-009-0882-2. Epub 2009 Oct 8.

  PMID: 19813011 BACKGROUND

• Naeem-Ur-Razaq M, Qasim M, Khan MA, Sahibzada AS, Sultan S. Management outcome of closed femoral shaft fractures by open Surgical Implant Generation Network (SIGN) interlocking nails. J Ayub Med Coll Abbottabad. 2009 Jan-Mar;21(1):21-4.

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MeSH Terms

Conditions

Tibial Fractures; Wounds and Injuries

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Fractures, Bone; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Saam Morshed, MD, MPH

  University of California, San Francisco

  STUDY CHAIR

• David Shearer, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Billy Haonga, MD

  Muhimbili Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

• Edmund Eliezer, MD

  Muhimbili Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 4, 2019
• Study Start: December 17, 2015
• Primary Completion: March 25, 2017
• Study Completion: March 25, 2017
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available upon publication. There is no expiration period for data availability.
• Access Criteria: Investigators requesting data access will be required to submit a cover letter and email to the primary study contact outlining their reasons for requesting data access and their plan for use of study data. All decisions to allow access will be determined by study principal investigators.