Intramedullary Nailing Versus External Fixation in Open Tibia Fractures in Tanzania
NCT ID: NCT03861624
Last Updated: 2022-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2015-12-17
2017-03-25
Brief Summary
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Detailed Description
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All enrolled participants were taken to the operating room for initial irrigation and debridement using a standardized protocol aiming for debridement within 24 hours of hospital admission. Preoperative ceftriaxone was given as soon as possible after presentation to the emergency department. Following debridement, the primary surgeon determined if the wound was amenable to immediate or delayed primary closure. If amenable to primary closure, the patient was randomized by a site research coordinator to one of two treatments (Intramedullary nailing (IMN) or external fixation (EF))using a centralized web-based electronic randomization tool, Research Electronic Data Capture (REDCap). The study computer analyst developed the REDCap randomization module with input from senior authors. The REDCap randomization module incorporated block randomization to maintain equal patient distribution between each treatment group and to ensure allocation concealment.
Data from a pilot study at the site of our investigation informed sample size calculations, which showed reoperation rates of external fixation and intramedullary nailing of 38% versus 3.8%. However, with longer follow-up and more stringent criteria for a primary event, The investigators used a more conservative effect size of 20% compared to 5%. Using a power of 80% and alpha of 0.05, The investigators calculated the study would require 88 patients in each treatment group (176 total). Accounting for 20% loss to follow up, The investigators estimated a total sample size requirement of 240 patients (120 per group).
Data monitoring was completed by the adjudication committee at 6 month intervals throughout the study duration and prior to final analysis in December, 2018.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intramedullary nailing
Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures via Intramedullary nailing with standard SIGN nail.
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.
External Fixation
Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures External Fixation with uniplanar Dispofix external fixator.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. AO/OTA 42 open tibia fractures
3. Wound primarily closeable (no flap or delay in closure due to contamination needed)
4. Palpable pedal pulses (no vascular injury sustained)
5. Presentation within 24 hours from injury
Exclusion Criteria
2. Sustained bilateral tibia fracture
3. Sustained comminuted femur fracture
4. Sustained severe Traumatic Brain Injury (GCS\<12) \*\*\*
5. Sustained severe spinal cord injury (lower extremity paresis/paralysis)
6. Sustained severe burns (\>10% total body surface area (TBSA) or \>5% TBSA with full thickness or circumferential injury)
7. Prior ipsilateral leg injury requiring surgery
8. Prior or current lower limb deformity or abnormality
9. Unable to complete follow-up visits
18 Years
ALL
No
Sponsors
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Wyss Foundation, Inc
UNKNOWN
Doris Duke Charitable Foundation
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Saam Morshed, MD, MPH
Role: STUDY_CHAIR
University of California, San Francisco
David Shearer, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Billy Haonga, MD
Role: PRINCIPAL_INVESTIGATOR
Muhimbili Orthopaedic Institute
Edmund Eliezer, MD
Role: PRINCIPAL_INVESTIGATOR
Muhimbili Orthopaedic Institute
References
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Chandran A, Hyder AA, Peek-Asa C. The global burden of unintentional injuries and an agenda for progress. Epidemiol Rev. 2010;32(1):110-20. doi: 10.1093/epirev/mxq009. Epub 2010 Jun 22.
Patton GC, Coffey C, Sawyer SM, Viner RM, Haller DM, Bose K, Vos T, Ferguson J, Mathers CD. Global patterns of mortality in young people: a systematic analysis of population health data. Lancet. 2009 Sep 12;374(9693):881-92. doi: 10.1016/S0140-6736(09)60741-8.
Mock C, Cherian MN. The global burden of musculoskeletal injuries: challenges and solutions. Clin Orthop Relat Res. 2008 Oct;466(10):2306-16. doi: 10.1007/s11999-008-0416-z. Epub 2008 Aug 5.
Beveridge M, Howard A. The burden of orthopaedic disease in developing countries. J Bone Joint Surg Am. 2004 Aug;86(8):1819-22. doi: 10.2106/00004623-200408000-00029.
WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.
Dormans JP, Fisher RC, Pill SG. Orthopaedics in the developing world: present and future concerns. J Am Acad Orthop Surg. 2001 Sep-Oct;9(5):289-96. doi: 10.5435/00124635-200109000-00002.
Museru LM, Mcharo CN. The dilemma of fracture treatment in developing countries. Int Orthop. 2002;26(6):324-7. doi: 10.1007/s00264-002-0408-7. Epub 2002 Oct 17. No abstract available.
Zirkle LG Jr. Injuries in developing countries--how can we help? The role of orthopaedic surgeons. Clin Orthop Relat Res. 2008 Oct;466(10):2443-50. doi: 10.1007/s11999-008-0387-0. Epub 2008 Aug 7.
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.
Shearer D, Cunningham, B., Zirkle, L. Population Characteristics and Clinical Outcomes from the SIGN Online Surgical Database. Techniques in Orthopaedics. 2009;24(4):273-276.
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.
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.
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.
Ikem IC, Ogunlusi JD, Ine HR. Achieving interlocking nails without using an image intensifier. Int Orthop. 2007 Aug;31(4):487-90. doi: 10.1007/s00264-006-0219-3. Epub 2006 Oct 13.
Sekimpi P, Okike K, Zirkle L, Jawa A. Femoral fracture fixation in developing countries: an evaluation of the Surgical Implant Generation Network (SIGN) intramedullary nail. J Bone Joint Surg Am. 2011 Oct 5;93(19):1811-8. doi: 10.2106/JBJS.J.01322.
Kooistra BW, Dijkman BG, Busse JW, Sprague S, Schemitsch EH, Bhandari M. The radiographic union scale in tibial fractures: reliability and validity. J Orthop Trauma. 2010 Mar;24 Suppl 1:S81-6. doi: 10.1097/BOT.0b013e3181ca3fd1.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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14-14792
Identifier Type: -
Identifier Source: org_study_id
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