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.: PACTR201703002109357 Date of Approval: 17/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical trial for fixation of paediatric femur fractures
Official scientific title Randomised clinical trial comparing flexible nail versus Kirschner wire for intramedullary fixation of paediatric femur fractures
Brief summary describing the background and objectives of the trial Femoral shaft fractures in children are common injuries1. The management of a paediatric femur fracture is dictated by patient age, fracture pattern, associated injuries, and the social and economic situation of the patient2,3. In children age 5-12, these fractures have historically been treated with skeletal traction. This technique has been associated with delayed union, malunion, knee stiffness, and place a high burden on the patients and their families due to prolonged bed rest and immobilization2,4,5. The introduction of flexible intramedullary nails has revolutionized the care of children with femur fractures. However, application of this technology is challenging in resource-limited settings due to high cost and implant availability5,6. Previously, we presented a comparison of flexible nail fixation versus traction for children with femoral shaft fractures at Komfo Anokye Teaching Hospital (KATH)7. This study found that while flexible nail fixation significantly decreased hospital length of stay, the costs associated with surgical treatment was high and often prohibitive. These findings demonstrate the need for low-cost alternatives to flexible nail implants. Recently, the use of intramedullary K-wire fixation has emerged as a low-cost alternative for fixation of diaphyseal femur fractures in children8-13. This technique applies the same principles of fixation as flexible nails while using commonly available and affordable implants. There have been several retrospective case series that have demonstrated good outcomes with K-wires for fixation of femoral shaft fractures8-14. Prior to expanding this technique more broadly, it is important to assess whether locally available K-wires are equivalent to flexible nails for intramedullary fixation of femoral shaft fractures in children. The purpose of this study is to compare the intramedullary K-wire to flexible nail for diaphyseal femur fractures in paediatric patients at KATH in Kumasi, Ghana.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatric femur fractures,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2017
Actual trial start date
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 randomisation using a radomisation 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 Intramedullary Kirschner wire fixation Once 6 months Intramedullary fixation of paediatric femoral shaft fracture with Kirschner wire 80
Control Group Intramedullary flexible nail fixation Once 6 months Intramedullary fixation of paediatric femoral shaft fracture with flexible nail 80 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All children age 5-14 admitted to KATH for acute traumatic diaphyseal fracture of the femur will be considered for inclusion in this study Skeletal maturity Head trauma Patient weight greater than 50 kg Metaphyseal or intra-articular femoral fracture Pathological fracture Segmental fracture patterns Significant bone loss Patients on drugs that affect fracture healing 5 Year(s) 12 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
No 16/02/2017 Committee on Human Research Publication and Ethics Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
P.O. Box 1934, Komfo Anokye Teaching Hospital Kumasi Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain free union without significant malalignment 2 weeks postoperatively 8 weeks postoperatively 26 weeks postoperatively 52 weeks postoperatively
Secondary Outcome Pediatric Quality of Life Inventory (PedsQL) 2 weeks postoperatively 8 weeks postoperatively 26 weeks postoperatively 52 weeks postoperatively
Secondary Outcome Pediatric Outcomes Data Collection Instrument (PODCI) 2 weeks postoperatively 8 weeks postoperatively 26 weeks postoperatively 52 weeks postoperatively
Secondary Outcome Recovery milestones (time to walking with aids, time to independent walking, time until full activity allowed) 2 weeks postoperatively 8 weeks postoperatively 26 weeks postoperatively 52 weeks postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Komfo Anokye Teaching Hospital Okomfo Anokye Road Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Institute for Global Orthopaedics and Traumatology 2550 23rd Street, Building 9, 2nd Floor San Francisco 94110 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institute for Global Orthopaedics and Traumatology 2550 23rd Street, Building 9, 2nd Floor San Francisco 94110 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Institute for Global Orthopaedics and Traumatology 2550 23rd Street, Building 9, 2nd Floor San Francisco 94110 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paa Kwesi Baidoo pakandval@gmail.com 233 206 300668 Komfo Anokye Teaching Hospital, Box 1934
City Postal code Country Position/Affiliation
Kumasi Ghana Senior Specialist
Role Name Email Phone Street address
Public Enquiries Patrick Curran patrick.curran@ucsf.edu +1 925 699 3256 2550 23rd Street ; Building 9, 2nd Floor
City Postal code Country Position/Affiliation
San Francisco 94110 United States of America Research Fellow
Role Name Email Phone Street address
Scientific Enquiries Patrick Curran patrick.curran@ucsf.edu +1 925 699 3256 2550 23rd Street ; Building 9, 2nd Floor
City Postal code Country Position/Affiliation
San Francisco 94110 United States of America Research Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information