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Trial registered on ANZCTR


Registration number
ACTRN12619001576112
Ethics application status
Approved
Date submitted
15/09/2019
Date registered
14/11/2019
Date last updated
28/06/2021
Date data sharing statement initially provided
14/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Midfix Randomized Controlled Trial – Does dorsal plating of Lisfranc injuries lead to better Manchester-Oxford Foot Questionnaire (MOxFQ) pain scores at 1 year compared to transarticular screw fixation? – A prospective randomized controlled trial
Scientific title
Midfix RCT – Does dorsal plating of Lisfranc injuries lead to better MOxFQ pain scores at 1 year compared to transarticular screw fixation? – A prospective randomized controlled trial
Secondary ID [1] 299248 0
Nil known
Universal Trial Number (UTN)
U1111-1240-2946
Trial acronym
Midfix RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lisfranc injury 314417 0
Condition category
Condition code
Musculoskeletal 312758 312758 0 0
Other muscular and skeletal disorders
Injuries and Accidents 313133 313133 0 0
Fractures
Surgery 313134 313134 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315566 0
Treatment: Devices
Intervention code [2] 315989 0
Treatment: Surgery
Comparator / control treatment
Control group is transarticular screw fixation, a widely accepted fixation method for lisfranc injuries. This involves a screw aimed across the midfoot joints to stabilise the area fractured.

A small incision is made over the area, generally over the dorsum of the foot. The joint is reduced under image intensifier and at times maintained with a kirchner wire. A screw is then passed across the joint to stabilise it. This procedure time is generally 90 minutes
Control group
Active

Outcomes
Primary outcome [1] 321386 0
Manchester-Oxford Foot Questionnaire pain scores
Timepoint [1] 321386 0
1 year post operatively
Secondary outcome [1] 374839 0
MOxFQ function score
Timepoint [1] 374839 0
At 1 year
Secondary outcome [2] 376250 0
EQ-5D quality of life score
Timepoint [2] 376250 0
At 1 year
Secondary outcome [3] 376251 0
Need for further surgery, such as for fixation failure, pain secondary to metalwork, or infection
Timepoint [3] 376251 0
At one year
Secondary outcome [4] 376252 0
Tertiary outcomes include monitoring for radiological signs of arthrosis
Timepoint [4] 376252 0
At one year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomized procedures will be inserted into individual opaque envelopes, each labelled with a trial number on the exterior. Once consent is obtained, an envelope with the next available trial number will selected. The treating surgical team will be notified to facilitate pre-operative planning.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur through block randomization through Strata, using the ralloc command.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis is conducted using validated questionnaire including MOxFQ, AOFAS, and EQ-5D scores. Results will be analysed to assess if difference between the groups are statistically significant. A power calculation has been conducted which indicates 49 individuals per group are required for sufficient power to assess the MOxFQ pain score.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2019
Actual
1/07/2020
Date of last participant enrolment
Anticipated
4/09/2022
Actual
Date of last data collection
Anticipated
10/09/2023
Actual
Sample size
Target
100
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14790 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 14791 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 28032 0
4215 - Southport
Recruitment postcode(s) [2] 28033 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 303784 0
Hospital
Name [1] 303784 0
Gold Coast University Hospital
Country [1] 303784 0
Australia
Primary sponsor type
Hospital
Name
Department of Orthopaedic Surgery - Gold Coast University Hospital
Address
1 Hospital Blvd
Southport, QLD, 4215
Country
Australia
Secondary sponsor category [1] 303905 0
None
Name [1] 303905 0
Address [1] 303905 0
Country [1] 303905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304305 0
The Gold Coast Hospital and Health District Human Research Ethics Committee
Ethics committee address [1] 304305 0
Ethics committee country [1] 304305 0
Australia
Date submitted for ethics approval [1] 304305 0
05/07/2019
Approval date [1] 304305 0
03/06/2020
Ethics approval number [1] 304305 0
HREC/2019/QGC/51236

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96466 0
Dr John Bilenki
Address 96466 0
Gold Coast University Hospital
1 Hospital Blvd, Southport, QLD, 4215
Country 96466 0
Australia
Phone 96466 0
+61 07 5687 0000
Fax 96466 0
Email 96466 0
john.bilenki@health.qld.gov.au
Contact person for public queries
Name 96467 0
John Bilenki
Address 96467 0
Gold Coast University Hospital
1 Hospital Blvd, Southport, QLD, 4215
Country 96467 0
Australia
Phone 96467 0
+61 07 5687 0000
Fax 96467 0
Email 96467 0
john.bilenki@health.qld.gov.au
Contact person for scientific queries
Name 96468 0
John Bilenki
Address 96468 0
Gold Coast University Hospital
1 Hospital Blvd, Southport, QLD, 4215
Country 96468 0
Australia
Phone 96468 0
+61 07 5687 0000
Fax 96468 0
Email 96468 0
john.bilenki@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data is not planned to be shared due to the volume of data to be collected during this study. Expected participants approximately 100, each filling out 3 questionnaires at 5 different time points


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4793Study protocolSee attachment   378352-(Uploaded-09-11-2019-20-50-20)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.