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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04986267




Registration number
NCT04986267
Ethics application status
Date submitted
6/07/2021
Date registered
2/08/2021

Titles & IDs
Public title
The Effects of Hormonal Contraceptives on Incidence of ACL Injury Within Menstrual Cycle Phases
Scientific title
The Effects of Hormonal Contraceptives on Incidence of ACL Injury Within Menstrual Cycle Phases
Secondary ID [1] 0 0
Buckley_2021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Rupture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - ACL Rupture

ACL Rupture - Female, aged 18-40 years of age with an acute ACL rupture of the knee that occurred within the last 3 months, who presented to a sports or orthopaedic clinic


Other interventions: ACL Rupture
Female, aged 18-40 years of age with an acute ACL rupture of the knee that occurred within the last 3 months, who presented to a sports or orthopaedic clinic
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Type
Timepoint [1] 0 0
Baseline
Secondary outcome [1] 0 0
ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Use
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
ACL Injury Menstrual Cycle Phase Overall
Timepoint [2] 0 0
Baseline

Eligibility
Key inclusion criteria
* Presenting to a sports or orthopaedic clinic with an acute ACL rupture of their knee that occurred within the last 3 months
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2024
Sample size
Target
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
UniSA Allied Health and Human Performance - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of South Australia
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jon Buckley, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 8 8302 1853
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04986267