Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001110178
Ethics application status
Approved
Date submitted
20/06/2019
Date registered
12/08/2019
Date last updated
21/05/2021
Date data sharing statement initially provided
12/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Survival of ACL Reconstruction in Athletes
Scientific title
Survival of ACL Reconstruction in Athletes
Secondary ID [1] 298553 0
Nil
Universal Trial Number (UTN)
U1111-1235-7608
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anterior cruciate ligament injury 313380 0
Condition category
Condition code
Musculoskeletal 311815 311815 0 0
Other muscular and skeletal disorders
Injuries and Accidents 312201 312201 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Completion of questionnaire documenting further knee injuries, return to sport, and patient reported outcomes in a series of athletes at 3-12 years after ACL reconstruction. Results will be grouped according to sport of primary injury to determine the incidence of reinjury and return to sport across sporting populations. This is estimated to take 5-7 minutes to complete
Intervention code [1] 314808 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320485 0
ACL graft rupture assessed by questionnaire of any reinjury
Questionnaire was designed specifically for the study
Timepoint [1] 320485 0
Minimum 3 - 13 years after ACL reconstruction
Primary outcome [2] 320830 0
Contralateral ACL rupture assessed by questionnaire of any reinjury
Questionnaire was designed specifically for the study
Timepoint [2] 320830 0
Minimum 3 -13 years after ACL reconstruction
Secondary outcome [1] 371777 0
Patient reported rate of return to sports assessed by questionnaire designed specifically for study and Cincinnati Sports Activity Scale
Timepoint [1] 371777 0
3-13 years after ACL reconstruction
Secondary outcome [2] 372976 0
Psychological readiness to return to sport assessed by ACL-RSI score
Timepoint [2] 372976 0
3-13 years after ACL reconstruction

Eligibility
Key inclusion criteria
• ACL reconstruction between 2007 and 2015 performed by Leo Pinczewski or Justin Roe
• Primary injury sport of soccer, netball, skiing, rugby or basketball
• Willingness to give oral or digital informed consent, and willingness to participate to and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who are deceased
Subjects who are unable or unwillingly to complete a questionnaire in English

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Statistical analysis will be performed using SPSS software (IBM Corp). Statistical significance will be set at P< .05. The probability of failure will be estimated as a function of time using the Kaplan-Meier survival method. Survival tables at 1, 2, 5, 10 years will be collated. Comparisons of survival curves will be made with the univariate Cox proportional hazards model. Factors that are significant (p<.05) or nearly significant (p< .10) on univariate analysis will be entered into multivariate Cox regression analysis. Factors are then eliminated one at a time in a stepwise fashion until only the independent significant factors remain.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/06/2019
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
2100
Accrual to date
1533
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 14029 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 26819 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 303096 0
Other Collaborative groups
Name [1] 303096 0
North Sydney Orthopaedic Research Group
Country [1] 303096 0
Australia
Primary sponsor type
Other Collaborative groups
Name
North Sydney Orthopaedic Research Group
Address
The Mater Clinic Suite 2
3-9 Gillies St Wollstonecraft NSW 2065
Country
Australia
Secondary sponsor category [1] 303086 0
None
Name [1] 303086 0
Address [1] 303086 0
Country [1] 303086 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303640 0
St Vincents Human Research Ethics Committee
Ethics committee address [1] 303640 0
390 Victoria St
Darlinghurst NSW 2010
Ethics committee country [1] 303640 0
Australia
Date submitted for ethics approval [1] 303640 0
10/10/2018
Approval date [1] 303640 0
05/11/2018
Ethics approval number [1] 303640 0
SVH 18/225

Summary
Brief summary
Potential participants will be identified from an existing database of knee surgery with ethical approval. If the sport of injury is undocumented then the participants medical record will be reviewed, which is within the parameters of the approved database. Participants will be contacted via email where possible and invited to complete the questionnaire online, using RedCap questionnaire which is hosted on a secure medical server at St Vincent’s Hospital. The questionnaire should take less than 5 minutes to complete. Participants who are unable or unwilling to complete the questionnaire online will be invited to complete a paper copy of the questionnaire, which can be posted to them and include a reply paid envelope.

The questionnaire will consist of the ACL RSI scale, which is a disease specific, reliable and validated questionnaire for ACL injuries. Participants will also be asked if they have made a return to sport, whether any of their direct family members have had ACL injuries, and if they have sustained any further injuries to their knees. Results will be grouped according to sport of primary injury to determine the incidence of reinjury and return to sport across sporting populations.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94362 0
A/Prof Leo Pinczewski
Address 94362 0
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2 The Mater Clinic
3-9 Gillies St Wollstoencraft NSW 2065
Country 94362 0
Australia
Phone 94362 0
+61 2 9409 0500
Fax 94362 0
Email 94362 0
[email protected]
Contact person for public queries
Name 94363 0
Dr Lucy Salmon
Address 94363 0
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2 The Mater Clinic
3-9 Gillies St Wollstoencraft NSW 2065
Country 94363 0
Australia
Phone 94363 0
+61 2 9409 0500
Fax 94363 0
Email 94363 0
[email protected]
Contact person for scientific queries
Name 94364 0
Dr Lucy Salmon
Address 94364 0
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2 The Mater Clinic
3-9 Gillies St Wollstoencraft NSW 2065
Country 94364 0
Australia
Phone 94364 0
+61 2 9409 0500
Fax 94364 0
Email 94364 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2395Ethical approval    377826-(Uploaded-20-06-2019-10-42-59)-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.