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Trial registered on ANZCTR


Registration number
ACTRN12619000688189p
Ethics application status
Not yet submitted
Date submitted
30/04/2019
Date registered
7/05/2019
Date last updated
7/05/2019
Date data sharing statement initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing two methods of surgery for cartilage defects of the talus, using a functional assessment at one year post-operation.
Scientific title
Comparison of microfracture and Autologous Bio-scaffold Enhanced Chondrogenesis (ABEC) in treatment of osteochondral lesions of the talus: A prospective, randomized study (MALT)
Secondary ID [1] 298111 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MALT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteochondral Injuries of the talus 312643 0
Condition category
Condition code
Surgery 311137 311137 0 0
Surgical techniques
Injuries and Accidents 311169 311169 0 0
Other injuries and accidents
Musculoskeletal 311170 311170 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Microfracture plus Autologous Bio-scaffold Enhanced Chondrogenesis (ABEC)
Randomised intervention patients.
JointRep is a clot stabiliser designed to maintain the pro-chondrogenetic factors released following microfracture in a defect for a longer period.
Each patient will have a diagnostic ankle arthroscopy using medial and lateral portals. Lesion debrided with subsequent creation of stable smooth surrounding articular surface. Microfracture performed with an awl. The subchondral plate is plate punctured 3-4mm apart, from the peripheral to the centre of the lesion. Additional procedures performed as required.

JointRep to be utilised as per the manufacturer instructions: JointRep prepared during arthroscopy. The defect localised with a 14-gauge needle. The inflow irrigation is stopped, the arthroscope removed but the sleeve is left in. An air circulation is created inside the joint with an inflow sleeve and an outflow suction cannula which is allowed to run for a few minutes. Arthroscope returned to joint. Surgeon injects the desired volume of JointRep™ into the defect under direct visualization. After 2-3 minutes of immobilisation of the ankle, the joint is then closed. This additional step will take 5 minutes. The microfracture which will be performed in both intervention and control groups is variable, dependent on the complexity of the debridement and requirement for additional procedures, but is likely to be less than 1 hour surgical time.
This will occur in the operating theatre of the designed orthopaedic surgeon. It will happen once. The person administrating the intervention will be a trained orthopaedic surgeon or designated registrar.
Intervention code [1] 314337 0
Treatment: Surgery
Comparator / control treatment
Microfracture only
Randomised control group
Each patient will have a diagnostic ankle arthroscopy using medial and lateral portals. Lesion debrided with subsequent creation of stable smooth surrounding articular surface. Microfracture performed with an awl. The subchondral plate is plate punctured 3-4mm apart, from the peripheral to the centre of the lesion. Additional procedures performed as required.
Duration of surgery is variable, dependent on the complexity of the debridement and requirement for additional procedures, but is likely to be less than 1 hour surgical time.
This will occur in the operating theatre of the designed orthopaedic surgeon. It will happen once. The person administrating the intervention will be a trained orthopaedic surgeon or designated registrar.
Control group
Active

Outcomes
Primary outcome [1] 319910 0
The foot and ankle ability measure - a patient reported outcome (FAAM)
Timepoint [1] 319910 0
12 months
Secondary outcome [1] 369834 0
The patient's own assessment of their function of the foot and ankle, assessed using the FAAM
Timepoint [1] 369834 0
3, 6, 24 and 60 months
Secondary outcome [2] 369835 0
UCL pain, assessed using a 100mm visual analogue scale (VAS)
Timepoint [2] 369835 0
3, 6, 12, 24, 60 months
Secondary outcome [3] 369836 0
Range of motion assessed using a goniometre in clinic by the reviewing surgeon or registrar - likely the operative surgeon.
Timepoint [3] 369836 0
3 and 12 months
Secondary outcome [4] 369837 0
Complication rate - e.g. infection, deep vein thrombosis, failure of formation of cartilage - assessed clinically as usual practice without specific additional investigation unless clinical suspicion.
Timepoint [4] 369837 0
3 months, 12 months
Secondary outcome [5] 369838 0
MRI MOCART scores - evidence of cartilage repair or quality (this is likely to be a smaller group of patients, but is dependent on funding and cost. Selection is likely to either be location based or a set number of consecutive patients (i.e. the first 50) - this is still being debated as a group
Timepoint [5] 369838 0
12 months
Secondary outcome [6] 369948 0
Return to work - Assessed as normal work, with employment type recorded (i.e. sedantry, manual, etc), using part of the questionnaires specifically designed for this study.
Timepoint [6] 369948 0
6 or 12 weeks

Eligibility
Key inclusion criteria
• Symptomatic osteochondral lesion of the talus where microfracture has been offered, with at least 6 months of non-surgical management, as confirmed on MRI, in patients with skeletally mature ankles, aged 18 to 60 years old.
• Able to consent to trial inclusion
• Medically fit for surgery

Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Lesions too small to be considered for microfracture or a specific contra-indication to microfracture
• Declared intolerance or allergy to crustaceans or D-glucosamine
• Bipolar lesions (kissing lesions of the tibial plafond and talus)
• Diffuse arthritic changes
• Previous ankle operation
• Pregnancy
• Neuromuscular disorders
• Metabolic arthropathy
• Active infection
• Self-funded 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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Pragmatic - intervention and control groups may use different post op protocols - weight bearing and immobolisation is decided by the operating surgeon within guidelines
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This data will be presented using standard methods for statistical summaries of discrete and continuous data sets.

Standard statistical summaries (e.g. medians and ranges or means and variances, dependent on the distribution of the outcome) and graphical plots showing correlations will be presented for the primary outcome measure and the secondary outcome measures. Baseline data will be summarized to check comparability between treatment arms, and to highlight any characteristic differences between those individuals in the study, those ineligible, and those eligible but withholding consent. The main analysis will investigate differences in the primary outcome measure between the two treatment groups on an intention-to-treat basis at 12 months post-recruitment. The significance in responses between treatment groups will be formally assessed using an independent samples t-test; based on an assumed approximate normal distribution for this outcome measure. Tests will be two-sided and considered to provide evidence for a significant difference if p-values are less than 0.05 (5% significance level). Estimates of treatment effects will be presented with 95% confidence intervals.
T test analysis of mean values between the two groups will be recorded. Average time to returned employment will also be compared using a test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21443 0
New Zealand
State/province [1] 21443 0

Funding & Sponsors
Funding source category [1] 302643 0
Self funded/Unfunded
Name [1] 302643 0
to be confirmed
Address [1] 302643 0
Country [1] 302643 0
Primary sponsor type
Government body
Name
Capital and Coast District Health Board (CCDHB)
Address
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 302558 0
None
Name [1] 302558 0
Address [1] 302558 0
Country [1] 302558 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303268 0
Health and Disability Ethics Committee
Ethics committee address [1] 303268 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 303268 0
New Zealand
Date submitted for ethics approval [1] 303268 0
11/05/2019
Approval date [1] 303268 0
Ethics approval number [1] 303268 0

Summary
Brief summary
This study aims to compare the outcomes of two different ways of treating cartilage injuries in the ankle. The different techniques are known as a) microfracture and b) micro-fracture with JointRep.
The current best surgical practice is to use the microfracture, however, a new technique, which uses JointRep, a specific type of gel, may offer potentially a more favorable outcome. In small cartilage injuries of the ankle that require surgery, the affected area is smoothed out, and then the bone is punctured. These puncture holes cause a small amount of bleeding. This blood forms a clot, from which chemicals encourage healing and formation of new tissue to fill the injured area of cartilage. JointRep is an injectable gel which can be applied during the same surgery. This has been shown to stabilize the clot. This may allow a more concentrated delivery of the healing factors from the blood.
participants will be randomized to either procedure.
Following surgery, all participants will have the same follow up in orthopaedic outpatient clinics along with regular physiotherapy sessions.
at each follow up clinic patients may be asked to complete a survey questionnaire about their recovery and function.
Alternatively, study follow up questionnaires (6 and 12 weeks, 6 and 12 months, 2 and 5 years) may also be collected via a secure online survey link sent via email. Some patients may be required to have an additional MRI scan of their ankle at 12 months following their injury to assess which treatment is showing a greater amount of healing tissue. For other patients participating in this study, they will require no additional tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93078 0
Mr Nigel Willis
Address 93078 0
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country 93078 0
New Zealand
Phone 93078 0
+64 04 385 5999
Fax 93078 0
Email 93078 0
Nigel.Willis@ccdhb.health.nz
Contact person for public queries
Name 93079 0
Mr Nigel Willis
Address 93079 0
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country 93079 0
New Zealand
Phone 93079 0
+64 04 385 5999
Fax 93079 0
Email 93079 0
Nigel.Willis@ccdhb.health.nz
Contact person for scientific queries
Name 93080 0
Mr Nigel Willis
Address 93080 0
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country 93080 0
New Zealand
Phone 93080 0
+64 04 385 5999
Fax 93080 0
Email 93080 0
Nigel.Willis@ccdhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data. All results.
When will data be available (start and end dates)?
Post-publication, 10 years following end of trial
Available to whom?
Case by case basis at the discretion of the Principle investigator, based on the reason for data and methodology of the proposed study
Available for what types of analyses?
Meta-anaylses.
How or where can data be obtained?
Following signed data protection agreement and agreement by principle investigator, as recommended by the information technology department of the hospital.
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 1969 0
Informed consent form
Citation [1] 1969 0
Link [1] 1969 0
Email [1] 1969 0
Other [1] 1969 0
Type [2] 1970 0
Study protocol
Citation [2] 1970 0
Link [2] 1970 0
Email [2] 1970 0
Other [2] 1970 0
Summary results
No Results