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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901523303171 Date of Registration: 24/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A clinical trial comparing casting and skin traction versus frame fixation to repair shin bone fractures
Official scientific title Feasibility of Ilizarov frame fiXation for closed Tibial fractures in Sierra Leone
Brief summary describing the background and objectives of the trial Injury results in the death of approximately 5.8 million people each year, as well as severe disability for survivors, the majority of which occur in developing countries. A large proportion of these injuries are fractures or broken bones, with one of the commonest being broken leg bones. Sierra Leone is a country in West Africa and is one of the world’s poorest countries with a very weak healthcare system. There are limited treatment options for patients who break the bones in their legs and many of them have to live with disability or die from their injuries. This study aims to examine the treatment of broken tibia (shin) bones in the main government hospital of Freetown (Sierra Leone's capital), called Connaught Hospital. At present the treatment options for these fractures are casting with plaster of Paris and skin traction. For many of these fractures, this treatment is less than ideal, and often can result in prolonged hospital stay and poor function during and after treatment. 20 patients will undergo treatment as usual, with plaster of Paris and skin traction. The results of this will be compared with 20 patients who will receive a surgical intervention known as Ilizarov frame fixation. This involves a surgical procedure where the fracture is held in place by metal pins and an external frame to hold the broken pieces of bone steady while they heal. We think the benefit of this will be that the patient can walk quicker, get home from hospital quicker and have better bone healing and quality of life in the end. A large part of the study will look to see if the frame can be put in safely in Connaught and what are the costs and benefits of the frame compared to the current treatment. We hope the results will contribute to the implementation of a cost-effective and sustainable fracture fixation service in the future.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) FIXT
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/02/2019
Actual trial start date
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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 Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ilizarov frame 3 months plus circular external fixation device 20
Control Group Treatment as usual 3 months plus plaster of paris +/- traction 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Aged 18 years or older 2. Able to provide written informed consent 3. Diagnosis of a closed diaphyseal tibial fracture with no intraarticular extension, and amenable to limb-sparing surgery following radiographic investigation 4. Fractures must have an angular deformity of 10 degrees or greater, or a displacement of greater than 50% in any plane at entry into the trial 5. Fracture sustained within 3 weeks of eligibility assessment 6. American Society of Anaesthesiologists (ASA) physical status ≤3 7. Capable of completing required questionnaires at time of consent 1. Open fractures 2. Undisplaced fractures 3. Concurrent fractures of any bone requiring operative or traction management (concurrent fracture of the ipsilateral fibular is permitted) 4. Pre-existing diabetes via finger prick capillary blood glucose check 5. Pre-existing neuropathy via clinical examination of a doctor 6. Pre-operative compartment syndrome via clinical examination of a doctor 7. Sickle cell disease by past medical history 8. Immunosuppression by past medical history 9. Pathological fractures by radiographic and clinical examination 10. Lower limb lymphatic filariasis by clinical examination 11. Any previous involvement in the before or after arm of the trial 12. Patients who reside outside of the Western region catchment area 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 150 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 19/12/2018 Sierra Leone Scientific Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
5th Floor, Youyi Building Freetown 000000 Sierra Leone
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The fracture angular deformity at 3 months post-management, as defined by overall angular deformity on long leg alignment views via anteroposterior and lateral plain radiographs 3 month
Secondary Outcome The following will be assessed after 30 and at 3 months post-management: 1. Length of hospital stay, defined as the time between registration into trial and actual discharge date or censored at end of trial follow-up 2. Date of being medically fit for discharge, defined as the time between entry into the trial and clinical assessment concluding the patient is medically fit for discharge or censored at end of trial follow-up 3. Time to fully weight bear, defined as the ability to mobilise unaided based on clinical evaluation by a member of the caring team 4. Time to patient rerun to work or pre-morbid responsibilities (e.g. caregiving) if not employed and is self-defined by patient 5. Patient self-reported functional status, assessed using the Lower Limb Functional Index (LLFI) 6. Quality of life, assessed using the EuroQol-5D (EQ5D) 30 day and 3 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Connaught Hospital Freetown Freetown Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health Research UK London London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor College of Medicine and Allied Health Sciences University of Sierra Leone Freetown Sierra Leone University
COLLABORATORS
Name Street address City Postal code Country
University of Leeds Leeds Leeds United Kingdom
University of Sierra Leone A.J Momoh Street Freetown Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Bundu bunduibrahim@gmail.com +23276640898 Connaught Hospital
City Postal code Country Position/Affiliation
Freetoqn Sierra Leone Orthopaedic Surgeon
Role Name Email Phone Street address
Scientific Enquiries William Bolton w.s.bolton@leeds.ac.uk +447803336202 University of Leeds
City Postal code Country Position/Affiliation
Leeds United Kingdom Clinical Research Fellow
Role Name Email Phone Street address
Public Enquiries Cheryl Harris c.a.harris@leeds.ac.uk +447803336202 University of Leeds
City Postal code Country Position/Affiliation
Leeds United Kingdom Programme Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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