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.: PACTR201702001960109 Date of Approval: 03/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treatment of supracondylar humerus fractures in children
Official scientific title Comparison between crossing wires versus two lateral wires in the management of displaced supracondylar humerus in children
Brief summary describing the background and objectives of the trial Supracondylar humerus fractures in children are the most common occuring fractures in children usually in the first decade of life. these fractures occur as a result of a fall on outstretched hand. Classification accordind to the degree of diplacement into four types ( Gartland's classification). Treatment of diplaced fractures (II and III) is by closed reduction and fixation by either crossing wires or two lateral wires. most common complications that occurs in these fractures are pin tract infection, neurovascular injury from the fracture fragments or during pinning of the fracture. Also, mal union (cubitus varus or valgus) due to malreduction and stifness may also occurs. The aim of the study is to compare the outcomes of fixation using crossing wires versus lateral wires in the management of supracondylar humerus fractures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,supracondylar humerus fractures in children
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 06/01/2016
Actual trial start date 18/01/2016
Anticipated date of last follow up 28/09/2016
Actual Last follow-up date 28/09/2016
Anticipated target sample size (number of participants) 28
Actual target sample size (number of participants) 28
Recruitment status Stopped early/ terminated
Publication URL 2801
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group crossing wires group two crossing wires for 4 weeks closed reduction and then insertion of the lateral wire first and then insertion of the medial wire 14 Active-Treatment of Control Group
Control Group Lateral wires group two lateral wires 4 weeks Closed reduction then insertion of the two lateral wires 14 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Children between two and nine years. ¿ Unilateral fractures ¿ Displaced fractures ( gartland II and III ) ¿ Presenting within 72 hours from trauma ¿ No associated fractures in the same limb ¿ No previous fractures in the same limb ¿ Open fractures. ¿ Failed closed reduction. ¿ Floating elbow. ¿ Failure to preform preoperative neurovascular assessment ¿ Neurovascular injury requiring surgical exploration 2 Year(s) 9 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 15/06/2016 Research ethics comittee, faculty of medicine, Suez Canal university
Ethics Committee Address
Street address City Postal code Country
4.5 km ring road Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome radiolgical outcomes immediate postoperative two weeks postoperative four weeks postoperative after removal of the slab and the wires
Secondary Outcome grading of the clinical outcomes six weeks after intervention every two weeks after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
orthopedic department, Suez Canal university hospital 4.5 km ring road Ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Health Insurance 33 Galaa street, downtown cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Health Insurance 33 Galaa street, downtown cairo 11562 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
suez canal university hospital 4.5 km ring road ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Hassan doc.m.a.h89@gmail.com +201010656192 13 fouad aziz ghaly_ al hayat market_al sheikh zayed
City Postal code Country Position/Affiliation
ismailia 41516 Egypt resident
Role Name Email Phone Street address
Public Enquiries Hesham abdelsadek heshamsadeq58@yahoo.com +201221186571 4.5 km ring road
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt professor in orthopedic department, suez canal university hospital
Role Name Email Phone Street address
Scientific Enquiries Ashraf Abd el kafy ashraf.abdalkafy@gmail.com +201223634005 Intersection between Adly & Saad Zaghloul streets No. 14 - Marlyn Tower, in front of Omar Effendi Store - 2nd floor - Apartment 3
City Postal code Country Position/Affiliation
ismailia 41522 Egypt Assisstant professor in orthopedic department , suez canal university hospital
REPORTING
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