Contact information
Type
Scientific
Primary contact
Dr Juul Achten
ORCID ID
Contact details
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
j.achten@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7111
Study information
Scientific title
Acronym
Management of Distal Tibia
Study hypothesis
The aim of the project is to perform a pragmatic pilot trial comparing two modes of treatments of distal tibia fractures. The two commonest treatment modalities are intramedullary nailing (where the nail is inserted in the tibia across the fracture) and screw and plate fixation. There is no agreement in the literature as to which treatment is best. The literature has shown that complications following the treatments mentioned above are very similar between the two modalities (infection, mal-union and non-union and re-operations) but no one has looked at the actual function of the patients following one treatment compared to the other. The objective is therefore to compare the two modes of treatments for distal tibia fractures, in terms of patient disability rating and quality of life.
Ethics approval
MREC approved (ref: 8/H1210/1)
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention
1. Intramedullary nailing: a nail is inserted in the tibia across the fracture
2. Screw and plate fixation: a plate and screw are used to fix the fracture
Follow-up length: 12 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Disability Rating Index. The principle measurement of the primary outcome measure will be at one year after injury.
Secondary outcome measures
1. American Orthopaedic Foot and Ankle Society Hind foot Scale at 3, 6 and 12 months post-injury
2. Complications including wound dehiscence, infection, mal-union, non-union, reoperations, time in hospital and return
3. EQ-5D at 3, 6 and 12 months post-injury
4. Olerud and Molander ankle score at 3, 6 and 12 months post-injury
Overall trial start date
01/03/2008
Overall trial end date
30/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned Sample Size: 24
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2008
Recruitment end date
30/09/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
AO Foundation (Switzerland)
Alternative name(s)
AO
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22529095
Publication citations
-
Results
Mauffrey C, McGuinness K, Parsons N, Achten J, Costa ML, A randomised pilot trial of "locking plate" fixation versus intramedullary nailing for extra-articular fractures of the distal tibia., J Bone Joint Surg Br, 2012, 94, 5, 704-708, doi: 10.1302/0301-620X.94B5.28498.