Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes

Study Overview
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Brief Summary
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The purpose of this research study is to examine the impact of one type of commonly used birth control pill on blood levels of relaxin and measure changes in knee movement to determine whether there are changes in joint instability (indicating the knee is less stable) that may predispose female athletes to injury. Women not on hormonal birth control will also be enrolled to analyze differences between athletes on and not on birth control and to evaluate typical relaxin levels and knee laxity when birth control pills are not used.

Official Title
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Do Oral Contraceptives Protect Against Anterior Cruciate Ligament Injuries in Female Athletes

Conditions
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Ligament Injury

Intervention / Treatment
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* Drug: Oral Contraceptive Pill, norethindrn a-e estradiol-iron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18 years of age or older Currently playing basketball, soccer, or volleyball at Loyola Marymount or Pepperdine If not currently on COC, regular menstrual cycle occurring every 21-35 days Exclusion Criteria: Previous ACL injury Underlying neuromuscular disease Medical contraindication to COC use History of pregnancy Desire to conceive in the next year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Contraceptive Pill<br>Oral contraceptive, 1/day, for one year | Drug: Oral Contraceptive Pill, norethindrn a-e estradiol-iron<br>* tablet<br>* Other names: Blisovi 24 Fe 1 mg-20 mcg;|
| No Intervention: No Oral Contraceptive<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ligamentous injury | ligament rupture or tear occurrence per athlete enrolled | over the course of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum relaxin level | level of relaxin measured in each subject | baseline, 4 month visit | 
| Anterior Knee Laxity | Anterior Knee laxity will be evaluated using the KT-2000 and measured in millimeters of anterior translation of the tibia relative to the femur | baseline, 4 month visit | 
| Hip rotation during a single-legged drop | Hip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment. | baseline, 4 month visit | 
| Knee rotation during a single-legged drop | Hip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment. | baseline, 4 month visit | 
| Joint Hypermobility | Beighton score will be used to assess overall joint laxity. The Beighton score is on a nine-point scale that is based on 5 joint maneuvers. The maximum score is 9, which indicates hyperlax. A score of zero indicates tight joints. | baseline, 4 month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior cruciate ligament, birth control, oral contraceptive