None listed
Conditions
Brief summary
The primary purpose of this study is to further compare and analyse dorsal plate vs transarticular screw fixation in Lisfranc injuries through a randomized controlled trial. The primary outcome is improvement of pain post-operatively, as assessed by the Manchester-Oxford Foot Questionnaire (MOxFQ) pain score. Secondary outcomes include, MOxFQ function score, EQ-5D quality of life score, AOFAS midfoot scores and need for further surgery, such as for fixation failure, pain secondary to metalwork and infection. Tertiary outcomes include monitoring for radiological signs of arthrosis/joint fusion. These outcomes have been selected to further examine the factors important to patient satisfaction, as well as the factors to likely require further surgery either acutely or in the future.
Interventions
To compare traditional transarticular screw fixation to more current dorsal plating techniques for fixation of Lisfranc injuries, using pain as scored by the MOxFQ. Secondary outcomes include function and quality of life scores, as well as need for metal work removal and arthrosis. The working hypothesis is that dorsal plating has improved pain, as well as improved secondary outcomes, compared to transarticular screws due to less iatrogenic joint trauma.
The procedures include either dorsal pla
To compare traditional transarticular screw fixation to more current dorsal plating techniques for fixation of Lisfranc injuries, using pain as scored by the MOxFQ. Secondary outcomes include function and quality of life scores, as well as need for metal work removal and arthrosis. The working hypothesis is that dorsal plating has improved pain, as well as improved secondary outcomes, compared to transarticular screws due to less iatrogenic joint trauma. The procedures include either dorsal plating or transarticular screws. Dorsal plating involves placing a plate across the joints involved on the dorsal surface of the foot. Screws enter the bone without any implant crossing the joint. Transarticular screw fixation places a screw across the joints involved. Duration of procedure is dependant on the number of joints involved, typical procedure time is 90 minutes. All procedures will be performed by a qualified consultant orthopaedic surgeon.
Sponsors
Department of Orthopaedic Surgery - Gold Coast University Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The study population includes adults (those over the age of 18), with a Lisfranc injury confirmed on weight bearing bilateral foot radiographs, or CT scan. This is diagnosed on weightbearing radiographs as a difference of greater than 2 millimetres of space between the distal lateral border of the medial cuneiform and the medial base of the second metatarsal, or greater than 1 millimetre difference as compared to the non-injured side. In patients who cannot weight bear, a non-weightbearing radiograph or CT is used for diagnosis. Signs indicating a Lisfranc injury include complete discontinuity of a line drawn from the medial base of the second metatarsal to the medial border of the middle cuneiform on AP radiograph; a bony fragment in the first intermetatarsal space (also known as fleck sign), indicative of an avulsion of the Lisfranc ligament; dorsal displacement of the proximal base of the first or second metatarsal on a lateral radiograph or sagittal CT sequence.
Exclusion criteria
Exclusion criteria include individuals with insulin dependent diabetes mellitus, pre-existing charcot arthropathy, pre-existing foot or ankle injury or pathology limiting mobility/function, multitrauma (more than one fracture location), those who cannot appropriately provide consent, or the inability to follow up in Gold Coast University Hospital for 18 months. Additionally, patients must be medically well enough to undergo surgery.
Outcome results
None listed