Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202007730039055 Date of Approval: 08/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical Outcomes for Open Tibial Shaft Fractures: A Prospective Randomized Trial Comparing External Fixation to Unreamed Intramedullary Nailing in Uganda
Official scientific title Clinical Outcomes for Open Tibial Shaft Fractures: A Prospective Randomized Trial Comparing External Fixation to Unreamed Intramedullary Nailing in Uganda
Brief summary describing the background and objectives of the trial The optimal management of open tibial shaft fractures has remained a source of debate among orthopaedic surgeons. The overall approach has remained constant however: including immediate antibiotic administration, irrigation and debridement of the wound and bone ends within 24hrs, and early stabilization of the fracture.11 The current standard of care in Uganda is stabilization with external fixation, following by removal of the external fixation device and cast application when the wounds are healed and fracture callous formed. In higher-income countries, a generally accepted stabilization method for open tibial shaft fracture is with unreamed IM nail. The goal of this trial is to determine the optimal method of fixation for high-energy, open tibial shaft fractures in Uganda.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 05/04/2016
Actual trial start date 07/04/2016
Anticipated date of last follow up 01/09/2021
Actual Last follow-up date 09/02/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 55
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Unmreamed intramedullary nail Single procedure An appropriately sized nail will be chosen preoperatively. Anatomic fracture reduction will be obtained and provisionally held. A trans-patellar tendon start point will be used, the position of which will be checked using intra-operative fluoroscopy. The nail will be advanced and secured using at least one distal and proximal locking bolt, again checking position with fluoroscopy. Simple fractures amenable to dynamic bolt fixation will be fixed accordingly. Wounds will be attempted to be closed primarily and IV antibiotics continued for 24hrs. Wounds that require secondary surgeries to close soft tissue defects (e.g. muscle flaps or split thickness skin grafts) are classified therefore as Gustilo Type IIIB and therefore will not be included in the final analysis. 25
Control Group External Fixation Single procedure After irrigation and debridement, provisional fixation will again be obtained. Two fixation pins distal to the fracture site and two proximal will be placed to stabilize the fracture, outside the open wound. On follow-up, the ex-fix will be replaced with a patella tendon bearing cast once fracture callus is observed on X-ray, to be kept in place another 4-6 weeks. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 110 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/04/2016 Mbarara University of Science and Technology Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 1410 Mbarara 1410 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Function IndeX for Trauma (FIX-IT) score 2-weeks, 4-8 weeks, 3-months, 6-months, and 12-months post injury
Secondary Outcome Euro-Qol 5-D 2-weeks, 4-8 weeks, 3-months, 6-months, and 12-months post injury
Secondary Outcome Radiographic healing Within 12-months of injury.
Secondary Outcome Malunion Within 12-months of injury.
Secondary Outcome Nonunion Within 12-month of injury.
Secondary Outcome Reoperation Within 12-months of injury.
Secondary Outcome Infection Within 12-months of injury.
Secondary Outcome Wound healing Within 12-months of injury.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbarara Regional Referral Hospital PO Box 1410 Mbararra Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
AOTrauma North America 1700 Russell Road Paoli United States of America
AO Alliance Foundation Clavadelerstrasse 8 Davos Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AO Alliance Foundation Clavadelerstrasse 8 Davos Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
David Stockton University of British Columbia Vancouver Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kisitu Kyengera kisitukd@yahoo.com +256782998487 PO Box 1410
City Postal code Country Position/Affiliation
Mbarara Uganda LecturerMbarara University of Science and Technology
Role Name Email Phone Street address
Public Enquiries Nathan OHara nohara@som.umaryland.edu +14103289579 110 South Paca St
City Postal code Country Position/Affiliation
Baltimore 21201 United States of America Research Associate University of Maryland
Role Name Email Phone Street address
Scientific Enquiries Nathan OHara nohara@som.umaryland.edu +14103289579 110 South Paca St.
City Postal code Country Position/Affiliation
Baltimore 21201 United States of America Research Associate University of Maryland
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual patient data will be made available as a supplement to the publication of the study's primary results. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol The summary results will be added to the trial registration within 12-months of completion. We also aim to publish the primary results within 12-months of study completion and will include IPD with the publication. The data will be open access, but de-identified IPD.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/03/2022 21/02/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/03/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information