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.: PACTR202009854874448 Date of Registration: 28/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Low-cost external fixators as definitive treatment of open tibial diaphyseal fractures
Official scientific title Low-cost external fixators as definitive treatment of open tibial diaphyseal fractures
Brief summary describing the background and objectives of the trial Increasing urbanization and the use of motorcycles in developing countries expose people to high-energy trauma. This is a source of many open lesions of the limbs, particularly in the tibial segment. The generally poor infrastructure and hygiene conditions make it almost impossible to properly treat open fractures using internal osteosynthesis techniques. Thus, the use of external devices provides an opportunity to improve the quality of treatment. There are numerous sophisticated models available on the market, but these are expensive. Many enterprising surgeons have therefore attempted to devise cheaper designs . There is no doubt that these fixators can achieve the same results as those that are more expensive, when used properly. The high costs of commercially available devices present a dilemma to the healthcare industry in poorer countries where there may be patients in need who are unable to afford optimum medical care. One way around this is to reduce the cost of manufacturing a typical fixator so that it is more affordable. This could be brought about by varying the choice of material to make the fixator, the overall product finish, and overall complexity of the design. With all these considerations in mind, the new low-cost external fixators (biplanar and unilateral) with biomechanical properties comparable to those of a validated reference fixator was specifically designed for the treatment of simple and comminuted patterns. These new designs are intended to provide a biomechanically reliable yet less expensive alternative to currently available devices. The materials used and the tools required are available in almost all developing countries. The construct’s stiffness is its decisive factor, as this ensures correct bone alignment under a mechanical load. The aim of this study was to evaluate the effectiveness of low-cost external fixator as definitive treatment for open tibia fracture.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/05/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 03/10/2020
Actual Last follow-up date 01/08/2020
Anticipated target sample size (number of participants) 37
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
033MSHPCHUBDGDMSONAR 033MSHPCHUBDGDMSONAR
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group treatment open tibia fracture by external fixators six month Treatment open tibial fracture by low-cost external fixators 40
Control Group Treatment by external fixator six month patient with open tibial diaphyseal fractures treated by external fixator as definitive treatment 40 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients over the age of 18 years Gustilo-Anderson type I,II,IIIA open tibial diaphyseal fractures Patients admitted to hospital within 24 hours of injury open tibial fractures with intra articular extension, open fractures type IIIB, type IIIC according to Gustilo-Anderson, those who had their initial débridement before arrival in our hospital those who have the negleted open tibial fractures 80 and over: 80+ Year,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) 80 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 18/02/2019 Direction medicale et scientifique du CHU de Bouake
Ethics Committee Address
Street address City Postal code Country
Odiennekorani Bouake Bouake 0225 Cote Divoire
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome rate of union eight months
Primary Outcome functionnal outcome eight months
Secondary Outcome outcomes complications eight months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre Hospitalier Universitaire de Bouake 01 BP 12885, rue Odiennekorani Bouake 0225 Cote Divoire
FUNDING SOURCES
Name of source Street address City Postal code Country
UCLouvain cooperation funding Avenue Mounier 53 Brussels 1200 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kouassi Kouame jean eric Ngattakro-Bouake bouake 00225 Cote Divoire Individual
COLLABORATORS
Name Street address City Postal code Country
AKOBE Jean Regis Zone -Bouake Bouake 00225 Cote Divoire
KOUASSI NATACHA AIR-FRANCE -BOUAKE BOUAKE 00255 Cote Divoire
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kouame Jean Eric Kouassi medericko@yahoo.fr 002507899242 Ngattakro-Bouake
City Postal code Country Position/Affiliation
Bouake 01 Cote Divoire University of Alassane Ouattara
Role Name Email Phone Street address
Principal Investigator Olivier Cornu olivier.cornu@uclouvain.be +32475387566 Avenue Mounier 53
City Postal code Country Position/Affiliation
Brussels 1200 Belgium Catholic Universy of Louvain
Role Name Email Phone Street address
Scientific Enquiries Michel Kodo prmkfr@yahoo.fr 0022507600550 AHOUGNANSSOU-BOUAKE
City Postal code Country Position/Affiliation
BOUAKE 01 Cote Divoire University of Alassane Ouattara
Role Name Email Phone Street address
Public Enquiries Alidou Traore tralidou@yahoo.fr 0022501087266 Cocody-Abidjan
City Postal code Country Position/Affiliation
Abidjan Cote Divoire University of Abidjan Cocody
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the de-indentified individual participant data collected during the trial will be made available after the end of the study Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Four months after article publication Co-authors' agreement
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