ANZCTR - Registration

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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]

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

Condition category

Condition code

Surgery

Surgical techniques

Injuries and Accidents

Other injuries and accidents

Musculoskeletal

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]

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]

The foot and ankle ability measure - a patient reported outcome (FAAM)

Timepoint [1]

12 months

Secondary outcome [1]

The patient's own assessment of their function of the foot and ankle, assessed using the FAAM

Timepoint [1]

3, 6, 24 and 60 months

Secondary outcome [2]

UCL pain, assessed using a 100mm visual analogue scale (VAS)

Timepoint [2]

3, 6, 12, 24, 60 months

Secondary outcome [3]

Range of motion assessed using a goniometre in clinic by the reviewing surgeon or registrar - likely the operative surgeon.

Timepoint [3]

3 and 12 months

Secondary outcome [4]

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]

3 months, 12 months

Secondary outcome [5]

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]

12 months

Secondary outcome [6]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/01/2020

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

170

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

to be confirmed

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

11/05/2019

Approval date [1]

Ethics approval number [1]

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

Mr Nigel Willis

Address

Wellington Regional Hospital
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 04 385 5999

Fax

Nigel.Willis@ccdhb.health.nz

Contact person for public queries

Name

Nigel Willis

Address

Wellington Regional Hospital
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 04 385 5999

Fax

Nigel.Willis@ccdhb.health.nz

Contact person for scientific queries

Name

Nigel Willis

Address

Wellington Regional Hospital
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 04 385 5999

Fax

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1969	Informed consent form					377505-(Uploaded-30-04-2019-18-46-33)-Study-related document.docx
1970	Study protocol					377505-(Uploaded-30-04-2019-18-47-12)-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.

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