The Effects of Hormonal Contraceptives on Incidence of ACL Injury Within Menstrual Cycle Phases

NCT04986267 | Completed

• 1 other identifier: Buckley_2021
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.There will be a higher proportion of ACL ruptures during the preovulatory phase of the menstrual cycle in non-hormonal contraceptive users.

Conditions

Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Type

  In which phase of the menstrual cycle did the ACL injury occur, by hormonal contraceptive type (including non-use reference)

  Baseline

Secondary Outcomes (2)

• ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Use

  Baseline

• ACL Injury Menstrual Cycle Phase Overall

  Baseline

Other Outcomes (7)

• ACL Injury Menstrual Cycle Phase, sensitivity analysis (Contact vs Non-Contact)

  Baseline

• ACL Injury Menstrual Cycle Phase, sensitivity analysis (Previous knee injury)

  Baseline

• ACL Injury Menstrual Cycle Phase, sensitivity analysis (playing history/level)

  Baseline

Study Arms (1)

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: ACL Rupture

Interventions

ACL Rupture OTHER

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

ACL Rupture

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Females who present to a sports or orthopaedic clinic with an ACL rupture that occurred within the previous 3 months

You may qualify if:

• Presenting to a sports or orthopaedic clinic with an acute ACL rupture of their knee that occurred within the last 3 months

Sponsors & Collaborators

• University of South Australia: lead

Study Sites (1)

UniSA Allied Health and Human Performance

Adelaide, South Australia, 5000, Australia

Location

Related Publications (10)

• 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.

  PMID: 32341803 BACKGROUND

• 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.

  PMID: 18539658 BACKGROUND

• 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.

  PMID: 30697162 BACKGROUND

• 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.

  PMID: 15911662 BACKGROUND

• 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.

  PMID: 18326833 BACKGROUND

• 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.

  PMID: 12073107 BACKGROUND

• 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.

  PMID: 4645131 BACKGROUND

• 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.

  PMID: 11912085 BACKGROUND

• 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.

  PMID: 18833305 BACKGROUND

• 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.

  PMID: 28795075 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Exercise Science

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 2, 2021
• Study Start: May 31, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

AU (1)