Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000412538p
Ethics application status
Submitted, not yet approved
Date submitted
2/03/2024
Date registered
4/04/2024
Date last updated
4/04/2024
Date data sharing statement initially provided
4/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Viable Cartilage Allograft in talar osteochondral lesions
Scientific title
Efficacy of Viable Cartilage Allograft in talar osteochondral lesions
Secondary ID [1] 311644 0
Nil
Universal Trial Number (UTN)
Trial acronym
eVAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteochondral Lesion in the Talus 333100 0
Condition category
Condition code
Musculoskeletal 329785 329785 0 0
Other muscular and skeletal disorders
Injuries and Accidents 329952 329952 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Osteochondral lesion of the talus are common and can be present in upto 6.5% of the population. While some may be asymptomatic, others can cause pain affecting lifestyle and potential lead to accelerated wear and potential arthritis. Traditionally microfracture has been the mainstay of surgical treatment however this can be associated with ongoing symptoms. The purpose of this pilot study is to assess the clinical efficacy of viable cartilage allograft in treating talar osteochondral lesions.

Patients enrolled in the study will receive Viable cartilage allograft. The viable cartilage allograft (CartiMax) is supplied by CONMED corporation.

As part of the procedure, an ankle arthroscopy will be performed in an operating theatre of a an Australian hospital. The lesion will be identified, prepared and the viable cartilage allograft will then be inserted. The surgery will take approximately 60 minutes. The surgeons involved are Australian trained foot and ankle orthopaedic surgeons with a number of years of experience. The surgeon performing the surgery will be implanting the allograft.
Intervention code [1] 328107 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337553 0
Foot and Ankle Outcome Score
Timepoint [1] 337553 0
Baseline, 6 weeks, 3, 6 and 12 months post surgery
Secondary outcome [1] 432311 0
General Health
Timepoint [1] 432311 0
Baseline, 6 weeks, 3, 6 and 12 months post surgery
Secondary outcome [2] 432312 0
Radiology for lesion resolution
Timepoint [2] 432312 0
3, 6 and 12 months post surgery
Secondary outcome [3] 432313 0
Radiology for lesion resolution
Timepoint [3] 432313 0
6 weeks, 3, 6 and 12 months post surgery
Secondary outcome [4] 432330 0
Adverse Events
Timepoint [4] 432330 0
2, 6 weeks; 3, 6 and 12 months post surgery

Eligibility
Key inclusion criteria
Patients between the ages of 18 to 65 (inclusive) undergoing surgery to treat talar osteochondral lesions will be included.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be bilateral surgery, revision procedures, not willing to participate in the trial, cognitive impairment that may impair the patient’s ability to follow post-operative instructions or unable to provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
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
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315973 0
Other
Name [1] 315973 0
Sydney Orthopaedic Foot and Ankle Research Institute
Country [1] 315973 0
Australia
Funding source category [2] 316230 0
Commercial sector/Industry
Name [2] 316230 0
Conmed Corporation
Country [2] 316230 0
Australia
Primary sponsor type
Other
Name
Sydney Orthopaedic Foot and Ankle Research Institute
Address
Country
Australia
Secondary sponsor category [1] 318114 0
Commercial sector/Industry
Name [1] 318114 0
CONMED Corporation
Address [1] 318114 0
Country [1] 318114 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314794 0
Ramsay Health Care Human Research Ethics Committee A
Ethics committee address [1] 314794 0
https://www.ramsayhealth.com.au/Ramsay-Research/Reseach-Ethics-at-Ramsay
Ethics committee country [1] 314794 0
Australia
Date submitted for ethics approval [1] 314794 0
29/05/2023
Approval date [1] 314794 0
Ethics approval number [1] 314794 0

Summary
Brief summary
Osteochondral lesion in talus can be challenging to treat leading to ongoing pain and loss of function. This study aims to investigate the efficacy of viable cartilage allograft for osteochondral talar dome lesions. The study hypothesis is: In patients with talus osteochondral lesions, viable cartilage allograft can improve patient pain and function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132754 0
A/Prof Rajat Mittal
Address 132754 0
Suite 10, Westmead Private Hospital, Cnr of Mons and Darcy Road, Westmead NSW 2145.
Country 132754 0
Australia
Phone 132754 0
+61 2 87552645
Fax 132754 0
Email 132754 0
rajatmittal.research@gmail.com
Contact person for public queries
Name 132755 0
Rajat Mittal
Address 132755 0
Suite 10, Westmead Private Hospital, Cnr of Mons and Darcy Road, Westmead NSW 2145.
Country 132755 0
Australia
Phone 132755 0
+61 2 87552645
Fax 132755 0
Email 132755 0
rajatmittal.research@gmail.com
Contact person for scientific queries
Name 132756 0
Rajat Mittal
Address 132756 0
Suite 10, Westmead Private Hospital, Cnr of Mons and Darcy Road, Westmead NSW 2145.
Country 132756 0
Australia
Phone 132756 0
+61 2 87552645
Fax 132756 0
Email 132756 0
rajatmittal.research@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.