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Trial registered on ANZCTR


Registration number
ACTRN12622000954729p
Ethics application status
Not yet submitted
Date submitted
2/12/2021
Date registered
6/07/2022
Date last updated
6/07/2022
Date data sharing statement initially provided
6/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Ligamentous Lisfranc injuries: a pilot multicentre randomised controlled trial examining primary arthrodesis versus fixation as best surgical treatment
Scientific title
Management of the Absolutely Ligamentous Lisfranc injury – Early fusion versus fixation Treatment: the mini-MALLET trial; a pilot randomised controlled trial
Secondary ID [1] 305946 0
Nil known
Universal Trial Number (UTN)
U1111-1250-6859
Trial acronym
mini-MALLET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lisfranc injuries 324541 0
Condition category
Condition code
Surgery 322010 322010 0 0
Other surgery
Musculoskeletal 323810 323810 0 0
Other muscular and skeletal disorders
Injuries and Accidents 323811 323811 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The mini-MALLET pilot trial is a feasibility, multi-centre, randomised controlled trial examining the functional, radiographic, and surgical outcomes of fusion versus (bridge plate) fixation of the ligamentous Lisfranc injury.
Current practice is to identify patients with a ligamentous Lisfranc injury through plain x-ray films as well as computerised tomography (CT) scans on review in emergency. This service is delivered as part of the Christchurch Hospital practice. Once identified as having a ligamentous Lisfranc injury, they would be offered operative treatment (as is considered the literature-backed norm) though the modality of this treatment (fixation versus fusion) is at the discretion of the operating surgeon. There is equipoise here, as neither option has been convincingly proven as superior to the other thus far in the known literature.
Under the pilot mini-MALLET trial, this same cohort of patients will be offered entry into the trial, wherein they would still receive treatment through the same service (the orthopaedic department of Christchurch Hospital) with study oversight from the trial investigators.
Their treatment would still be delivered through the hospital acutely (Christchurch Health Campus) and through the clinic (again at the Health Campus with occasional review in the Burwood clinic rooms, under the same District Health Board banner). They will be followed out to one year post their intervention.
Once entered into the trial, participants would be randomised to either fixation or fusion treatment.
Those in the fixation arm will receive an open surgical approach when the participant is surgically prepared (swelling appropriate, consented appropriately, and surgical time allowed) to the Lisfranc complex of the foot under general anaesthetic, reduction and then fixation of the joint(s) involved using plate and screws, and closure of the wound through surgeon’s preference.
They would then be discharged from hospital once cleared by the multi-disciplinary team of allied and medical health workers as safe for discharge, as is currently routine, to be followed up in clinic over the course of the next year.
Intervention code [1] 322337 0
Treatment: Surgery
Comparator / control treatment
As above regarding the details of the identification of patients and the broad overview of their journey through the hospital, the comparator is the fusion group.
With respect to the mode of delivery (surgery through the care of Christchurch Hospital with the study oversight provision through study investigators), location (Christchurch Health Campus and its facilities), and frequency (daily interaction on the ward acutely, with clinic follow up two weeks, six weeks, three months, six months, and one year post surgery), this is equivalent to the interventional group.
Those in the arthrodesis group will receive an open surgical approach to the Lisfranc complex under general anaesthetic, preparation, reduction and then fusion of the joint(s) involved using screws or plate and screws, and closure of the wound through surgeon’s preference. This differs from the fixation group as "preparation" of the joint refers to removal of remaining cartilage in the joint complex with the intention of creating a fusion block of multiple joints (rather than stabilising in place but maintaining a small amount of movement as is the joints' natural preference).
In literature, fusion performs superiorly for those Lisfranc injuries with a bony component.
Control group
Active

Outcomes
Primary outcome [1] 329781 0
A primary outcome is functional score through the SEFAS score (attained via the SEFAS questionnaire)
Timepoint [1] 329781 0
6 months post surgery, and 1 year post surgery
Primary outcome [2] 331599 0
Another primary outcome is the functional AOFAS score (attained via use of the AOFAS questionnaire)
Timepoint [2] 331599 0
6 months post surgery, and 1 year post surgery
Secondary outcome [1] 403750 0
Radiographic outcome (union) as determined by plain radiographs on clinic review. Markers include no failure of metalware, cortical continuity within the fusion block, and bony callous formation.
Timepoint [1] 403750 0
Out to one year post surgery. This will likely be within three months but may take longer to ascertain for some individual participants as healing rates differ.
Radiographs will be taken at three months, six months, and one year post surgery: determination of union will be ascertained through examination of these radiographs subsequently, and noted in the datasheet
Secondary outcome [2] 410450 0
Post-traumatic arthritis as evidenced on review of standard plain radiographs
Timepoint [2] 410450 0
1 year post surgery will be the definitive timepoint measure for development of post-traumatic arthritis.
Assessment of pain and function will be undertaken at three months, six months, and at one year. It is possible that post-traumatic arthritis is noted in a participant prior to the one year mark, but this is thought unlikely (and would be accordingly noted in the datasheet)
Secondary outcome [3] 410451 0
Secondary surgery as noted on review through clinic out to one year, in discussion with participants, and on audit of medical records
Timepoint [3] 410451 0
1 year post surgery will be the definitive timepoint measure for requirement of secondary surgery.
Assessment of development of complications will be undertaken at three months, six months, and at one year. It is possible that requirement for secondary surgery would be noted in a participant prior to the one year mark.
Secondary outcome [4] 410452 0
Complication rate as noted on discussion with participants through clinic reviews out to one year post surgery, and on audit of medical records. This may include infection, venous thromboembolism, and nerve injuries.
Timepoint [4] 410452 0
1 year post surgery will be the definitive timepoint for measurement of complications.

Assessment of complication development will be undertaken at three months, six months, and at one year. It is possible that complications would be noted in to have occurred for a participant prior to the one year mark, .
Secondary outcome [5] 410453 0
Surgical factors such as time taken, blood lost, wound closure method, and surgical fixation method utilised. This will be logged in a local datasheet on completion of the surgery by a trial investigator
Timepoint [5] 410453 0
Within one week from surgery
Secondary outcome [6] 410454 0
Return to sport and work as elucidated from participant review in clinic post surgery
Timepoint [6] 410454 0
Out to one year following surgery (this will be different for each participant but is anticipated to be well before the one-year mark for each).
Assessment of whether return to work and sport has occurred will be undertaken at three months, six months, and at one year.

Eligibility
Key inclusion criteria
• Patients aged 20 to 65
• Radiographically proven (CT and weightbearing plain films on presentation with the injury and/or initial complaint) ligamentous Lisfranc injury
o Widening of the Lisfranc interval (between the medial cuneiform and second metatarsal)
o No overt fracture noted on plain weightbearing films of the base of second metatarsal
o Small flakes of bone in keeping with avulsion on CT and/or plain film, regardless of location, provided a Lisfranc injury is present
• Comprehension of English and capacity to engage in rehabilitation program
• Time from injury <4 weeks
• All Lisfranc injuries (fracture present or not) evidenced on plain radiographs or CT will be recorded in incidence throughout the study period to indicate relative incidence of ligamentous Lisfranc injuries as a subset
Minimum age
20 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Previous foot and/or ankle injury requiring intervention such as casting or surgery
• Significant comorbidity such as diabetes with sequelae, moderate cardiac or respiratory disease
• Collagen or significant soft tissue disorder
• Severe obesity (BMI >40)
• Multiple injuries affecting the lower limb
• Substance or alcohol abuse
• Delayed presentation (>4 weeks)

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)
No concealment will occur
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
7/07/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 24365 0
New Zealand
State/province [1] 24365 0
Canterbury, Nelson Marborough

Funding & Sponsors
Funding source category [1] 310285 0
Charities/Societies/Foundations
Name [1] 310285 0
NZOA Wishbone Foundation
Country [1] 310285 0
New Zealand
Funding source category [2] 310303 0
Charities/Societies/Foundations
Name [2] 310303 0
AO Trauma Pacific Group
Country [2] 310303 0
Hong Kong
Primary sponsor type
Hospital
Name
Canterbury District Health Board (CDHB)
Address
2 Riccarton Ave
Christchurch 8011
New Zealand
Country
New Zealand
Secondary sponsor category [1] 311420 0
None
Name [1] 311420 0
Address [1] 311420 0
Country [1] 311420 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 309953 0
Health and Disability Ethics Committee
Ethics committee address [1] 309953 0
133 Molesworth Street
Thorndon 6011
Wellington
Ethics committee country [1] 309953 0
New Zealand
Date submitted for ethics approval [1] 309953 0
03/07/2022
Approval date [1] 309953 0
Ethics approval number [1] 309953 0

Summary
Brief summary
This pilot study aims to assess the feasibility of a larger, multi-centre randomised controlled trial in order to ascertain the best surgical management for the ligamentous Lisfranc injury of the foot.
Patients with x-ray and computerised tomography (CT) evidenced such injuries will be invited to be randomised to receive either open reduction internal fixation (ORIF) (5 patients) or arthrodesis (5 patients) as their surgical management.
Patients who are unable or decline to participate in the randomised controlled study will be invited to enter an observational parallel cohort. They will receive treatment as is still the norm for that institution.
The primary endpoints will be functional outcome as determined using the American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot Scale, and the Self-Reported Foot and Ankle Score (SEFAS) with secondary outcomes including radiographic analyses (plain xray films only), return to sport and work rate, secondary operation rate, and complications resultant from treatment; these will be collected at three months, six months, and one year following surgery.
Our primary hypothesis is that arthrodesis (fusion) will offer superior outcomes to ORIF
(fixation) for the management of the ligamentous Lisfranc injury significant at one year postoperatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115970 0
Dr Matthew D'Arcy
Address 115970 0
c/o Orthopaedic Department
2 Riccarton Ave 8011
Christchurch
Country 115970 0
New Zealand
Phone 115970 0
+64 210700814
Fax 115970 0
Email 115970 0
[email protected]
Contact person for public queries
Name 115971 0
Matthew D'Arcy
Address 115971 0
c/o Orthopaedic Department
2 Riccarton Ave 8011
Christchurch
Country 115971 0
New Zealand
Phone 115971 0
+64 210700814
Fax 115971 0
Email 115971 0
[email protected]
Contact person for scientific queries
Name 115972 0
Matthew D'Arcy
Address 115972 0
c/o Orthopaedic Department
2 Riccarton Ave 8011
Christchurch
Country 115972 0
New Zealand
Phone 115972 0
+64 210700814
Fax 115972 0
Email 115972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This data will not be made available publicly due to privacy concerns. Collated data, in deidentified fashion, will be available through submitted publications.


What supporting documents are/will be available?

No Supporting Document Provided



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.