Trial Review

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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
Scientific title
Clinical and Radiological Outcomes of Isolated Meniscal Repair in adolescent and adult patients
Secondary ID [1] 303636 0
None
Universal Trial Number (UTN)
U1111-1265-8828
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meniscal tear 321018 0
Meniscal injury 321019 0
Condition category
Condition code
Surgery 318818 318818 0 0
Other surgery
Musculoskeletal 318819 318819 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 319924 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326768 0
Clinical healing following an isolated meniscal repair, as evidenced by patient-reported outcome measures Patient reported outcome measure (IKDC)
Timepoint [1] 326768 0
12 months and 24 months post operatively
Primary outcome [2] 326769 0
Radiological healing following an isolated meniscal repair, as evidenced by MRI scan
Timepoint [2] 326769 0
Minimum 12 months postoperatively
Secondary outcome [1] 392629 0
Knee symptoms assessed using the Lyshom knee scoring system
Timepoint [1] 392629 0
12 & 24 months following the intervention
Secondary outcome [2] 405855 0
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).
Timepoint [2] 405855 0
12 and 24 months following intervention
Secondary outcome [3] 405898 0
Knee functions assessed using the Tegner activity scale
Timepoint [3] 405898 0
12 and 24 months following intervention

Eligibility
Key inclusion criteria
• Isolated meniscal repair surgery (irrespective of tear type)
Minimum age
15 Years
Maximum age
62 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/10/2020
Date of last participant enrolment
Anticipated
Actual
1/12/2020
Date of last data collection
Anticipated
1/10/2022
Actual
Sample size
Target
52
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308056 0
Self funded/Unfunded
Name [1] 308056 0
Country [1] 308056 0
Primary sponsor type
Other Collaborative groups
Name
Perth Orthopaedic and Sports Medicine
Address
31 Outram Street
West Perth WA 6005
Country
Australia
Secondary sponsor category [1] 308822 0
None
Name [1] 308822 0
Address [1] 308822 0
Country [1] 308822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308048 0
University of Western Australia
Ethics committee address [1] 308048 0
Ethics committee country [1] 308048 0
Australia
Date submitted for ethics approval [1] 308048 0
Approval date [1] 308048 0
01/06/2020
Ethics approval number [1] 308048 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109338 0
Dr Ross Radic
Address 109338 0
Mr Ross Radic Perth Orthopaedic and Sports Medicine Centre 31 Outram Street West Perth, WA, 6005
Country 109338 0
Australia
Phone 109338 0
+618 9212 4200
Fax 109338 0
Email 109338 0
[email protected]
Contact person for public queries
Name 109339 0
Tze Khiang Tan
Address 109339 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
Country 109339 0
Australia
Phone 109339 0
+61410649022
Fax 109339 0
Email 109339 0
[email protected]
Contact person for scientific queries
Name 109340 0
Tze Khiang Tan
Address 109340 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
Country 109340 0
Australia
Phone 109340 0
+61410649022
Fax 109340 0
Email 109340 0
[email protected]

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?

TypeCitationLinkEmailOther DetailsAttachment
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.