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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]

Buckley_2021

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anterior Cruciate Ligament Rupture

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Musculoskeletal

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]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Type

Timepoint [1]

Baseline

Secondary outcome [1]

ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Use

Timepoint [1]

Baseline

Secondary outcome [2]

ACL Injury Menstrual Cycle Phase Overall

Timepoint [2]

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?

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

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

UniSA Allied Health and Human Performance - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Primary sponsor type

Other

Name

University of South Australia

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

The aim of this study is to investigate how hormonal contraceptives affect ACL rupture incidence within menstrual cycle phases. It is thought hormones such as estrogen and progesterone (which fluctuate throughout the normal menstrual cycle) play a role in the laxity of ligaments within the body. It is hypothesised that around the time of ovulation the ACL undergoes increased laxity, leaving it more likely to be injured. This study will look at the phase of the menstrual cycle in which the ACL injuries occur and whether there are differences due to the use and type of hormonal contraception participants may be using (such as Combined oral contraceptive, Mirena, Implanon), which can modify the levels of circulating estrogen and progesterone.

This study involves participants completing an anonymous electronic survey after presenting to a sports or orthopaedic clinic with an ACL rupture. The survey collects information about participant's current ACL injury and any previous knee injuries; typical menstrual cycle patterns and the use of hormonal contraception; and history of sports participation. Responses will be analysed to look for similarities and differences in ACL injury occurrence by menstrual cycle phase and hormonal contraceptive use.

The study hypotheses are:

1. Hormonal contraceptives that are known to reduce ovulatory rises in estrogen will have the most consistent pattern of ACL rupture incidence across all phases of the menstrual cycle.
2. There will be a mitigated risk of ACL rupture in the preovulatory phase of the menstrual cycle, relative to the other phases, in women using hormonal contraception compared to those not using hormonal contraception
3. There will be a higher proportion of ACL ruptures during the preovulatory phase of the menstrual cycle in non-hormonal contraceptive users.

Trial website

https://clinicaltrials.gov/study/NCT04986267

Trial related presentations / publications

Fox A, Bonacci J, Hoffmann S, Nimphius S, Saunders N. Anterior cruciate ligament injuries in Australian football: should women and girls be playing? You're asking the wrong question. BMJ Open Sport Exerc Med. 2020 Apr 9;6(1):e000778. doi: 10.1136/bmjsem-2020-000778. eCollection 2020.
Renstrom P, Ljungqvist A, Arendt E, Beynnon B, Fukubayashi T, Garrett W, Georgoulis T, Hewett TE, Johnson R, Krosshaug T, Mandelbaum B, Micheli L, Myklebust G, Roos E, Roos H, Schamasch P, Shultz S, Werner S, Wojtys E, Engebretsen L. Non-contact ACL injuries in female athletes: an International Olympic Committee current concepts statement. Br J Sports Med. 2008 Jun;42(6):394-412. doi: 10.1136/bjsm.2008.048934.
Chidi-Ogbolu N, Baar K. Effect of Estrogen on Musculoskeletal Performance and Injury Risk. Front Physiol. 2019 Jan 15;9:1834. doi: 10.3389/fphys.2018.01834. eCollection 2018.
Ramesh R, Von Arx O, Azzopardi T, Schranz PJ. The risk of anterior cruciate ligament rupture with generalised joint laxity. J Bone Joint Surg Br. 2005 Jun;87(6):800-3. doi: 10.1302/0301-620X.87B6.15833.
Myer GD, Ford KR, Paterno MV, Nick TG, Hewett TE. The effects of generalized joint laxity on risk of anterior cruciate ligament injury in young female athletes. Am J Sports Med. 2008 Jun;36(6):1073-80. doi: 10.1177/0363546507313572. Epub 2008 Mar 7.
Deie M, Sakamaki Y, Sumen Y, Urabe Y, Ikuta Y. Anterior knee laxity in young women varies with their menstrual cycle. Int Orthop. 2002;26(3):154-6. doi: 10.1007/s00264-001-0326-0. Epub 2002 Apr 5.
Mishell DR Jr, Thorneycroft IH, Nakamura RM, Nagata Y, Stone SC. Serum estradiol in women ingesting combination oral contraceptive steroids. Am J Obstet Gynecol. 1972 Dec 1;114(7):923-8. doi: 10.1016/0002-9378(72)90098-1.
Wojtys EM, Huston LJ, Boynton MD, Spindler KP, Lindenfeld TN. The effect of the menstrual cycle on anterior cruciate ligament injuries in women as determined by hormone levels. Am J Sports Med. 2002 Mar-Apr;30(2):182-8. doi: 10.1177/03635465020300020601.
Beynnon BD, Shultz SJ. Anatomic alignment, menstrual cycle phase, and the risk of anterior cruciate ligament injury. J Athl Train. 2008 Sep-Oct;43(5):541-2. doi: 10.4085/1062-6050-43.5.541. No abstract available.
Herzberg SD, Motu'apuaka ML, Lambert W, Fu R, Brady J, Guise JM. The Effect of Menstrual Cycle and Contraceptives on ACL Injuries and Laxity: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2017 Jul 21;5(7):2325967117718781. doi: 10.1177/2325967117718781. eCollection 2017 Jul.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Jon Buckley, PhD

Address

Country

Phone

+61 8 8302 1853

Fax

jon.buckley@unisa.edu.au

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

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