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Trial registered on ANZCTR
Registration number
ACTRN12622000212752
Ethics application status
Approved
Date submitted
11/03/2021
Date registered
7/02/2022
Date last updated
7/02/2022
Date data sharing statement initially provided
7/02/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Clinical and Radiological Outcomes of Isolated Meniscal Repair
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Scientific title
Clinical and Radiological Outcomes of Isolated Meniscal Repair in adolescent and adult patients
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Secondary ID [1]
303636
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None
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Universal Trial Number (UTN)
U1111-1265-8828
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Meniscal tear
321018
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Meniscal injury
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Condition category
Condition code
Surgery
318818
318818
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0
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Other surgery
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Musculoskeletal
318819
318819
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The condition observed is isolated meniscal tears
medical records, study-specific survey on meniscal tear surgical repair outcomes
12 months postop follow up
Starting from the first hospital visit until 12 months post- procedure
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Intervention code [1]
319924
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Clinical healing following an isolated meniscal repair, as evidenced by patient-reported outcome measures Patient reported outcome measure (IKDC)
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Assessment method [1]
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Timepoint [1]
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12 months and 24 months post operatively
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Primary outcome [2]
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Radiological healing following an isolated meniscal repair, as evidenced by MRI scan
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Assessment method [2]
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Timepoint [2]
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Minimum 12 months postoperatively
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Secondary outcome [1]
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Knee symptoms assessed using the Lyshom knee scoring system
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Assessment method [1]
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Timepoint [1]
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12 & 24 months following the intervention
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Secondary outcome [2]
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Clinical and radiological outcome, MRI will be employed in all patients at a minimum 12 months post-surgery to evaluate the presence of healing (or failure).
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Assessment method [2]
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Timepoint [2]
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12 and 24 months following intervention
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Secondary outcome [3]
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Knee functions assessed using the Tegner activity scale
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Assessment method [3]
405898
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Timepoint [3]
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12 and 24 months following intervention
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Eligibility
Key inclusion criteria
• Isolated meniscal repair surgery (irrespective of tear type)
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Minimum age
15
Years
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Maximum age
62
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• The meniscal repair is combined with another knee surgery (or surgeries), such as ligament reconstruction.
• Degenerative changes of the knee (osteoarthritis) were present at the time of meniscal repair.
• Concurrent chondral or osteochondral injury was present at the time of meniscal repair.
• The individual is unable or unwilling to sign the Patient Informed Consent, specific to this study, and approved by the Institutional Ethics Review Board.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/10/2020
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Date of last participant enrolment
Anticipated
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Actual
1/12/2020
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Date of last data collection
Anticipated
1/10/2022
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Actual
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Sample size
Target
52
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Accrual to date
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Final
37
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
308056
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Country [1]
308056
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Primary sponsor type
Other Collaborative groups
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Name
Perth Orthopaedic and Sports Medicine
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Address
31 Outram Street
West Perth WA 6005
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
308822
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Address [1]
308822
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Country [1]
308822
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308048
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University of Western Australia
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Ethics committee address [1]
308048
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University of Western Australia 35 Stirling Hwy, Crawley WA 6009
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Ethics committee country [1]
308048
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Australia
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Date submitted for ethics approval [1]
308048
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Approval date [1]
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01/06/2020
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Ethics approval number [1]
308048
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Summary
Brief summary
Given the important role of meniscal repair in the restoration of normal knee mechanics and loading characteristics, the high prevalence of symptomatic meniscal tears, and the relative lack of published research in patients embarking on isolated meniscal repair, this study aims to ascertain the postoperative clinical and radiological outcome of patients undergoing varied surgical meniscal repair techniques (dictated by the nature, type and severity of the meniscal tear) for symptomatic and painful meniscal tears.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Ross Radic
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Address
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Mr Ross Radic Perth Orthopaedic and Sports Medicine Centre 31 Outram Street West Perth, WA, 6005
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Country
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Australia
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Phone
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+618 9212 4200
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Tze Khiang Tan
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Address
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Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
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Country
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Australia
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Phone
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+61410649022
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Fax
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Email
109339
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[email protected]
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Contact person for scientific queries
Name
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Tze Khiang Tan
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Address
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Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
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Country
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Australia
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Phone
109340
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+61410649022
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Fax
109340
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Email
109340
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Patient confidentiality
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
[email protected]
Study-related document.pdf
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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