Ligament Injury
Conditions
Keywords
anterior cruciate ligament, birth control, oral contraceptive
Brief summary
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.
Interventions
DRUGOral Contraceptive Pill, norethindrn a-e estradiol-iron
tablet
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Injury | over the course of 1 year | Any injury resulting in time away from practice or competition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Relaxin Level | baseline | level of relaxin measured in each subject |
| Anterior Knee Laxity | baseline | Anterior Knee laxity will be evaluated using the KT-2000 and measured in millimeters of anterior translation of the tibia relative to the femur |
| Hip Flexion at Initial Contact During a Single-legged Drop | baseline | Hip flexion measured during a singled-legged drop using motion tracking equipment. |
| Knee Adduction Rotation During a Single-legged Drop | baseline | inward rotation of the knee during max knee flexion measured during a singled-legged drop using motion tracking equipment. |
| Joint Hypermobility | baseline | 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 increased laxity in the joints. A score of zero indicates inflexible joints. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OCs Users Participant athletes regularly took oral contraceptives or had a hormone-containing IUD. | 31 |
| Non-OCs Participant athletes were not on any form of contraception. | 42 |
| Total | 73 |
Baseline characteristics
| Characteristic | OCs Users | Non-OCs | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 40 Participants | 70 Participants |
| Age, Continuous | 21.3 years STANDARD_DEVIATION 3.3 | 21.9 years STANDARD_DEVIATION 3.7 | 21.6 years STANDARD_DEVIATION 3.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 31 Participants | 42 Participants | 73 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 42 |
| other Total, other adverse events | 0 / 31 | 0 / 42 |
| serious Total, serious adverse events | 0 / 31 | 0 / 42 |
Outcome results
Primary
Injury
Any injury resulting in time away from practice or competition
Time frame: over the course of 1 year
Population: collegiate and professional female athletes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Contraceptive Pill | Injury | 8 Participants |
| No Oral Contraceptive | Injury | 16 Participants |
Secondary
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
Time frame: baseline, 4 month visit
Secondary
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.
Time frame: baseline, 4 month visit
Secondary
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 increased laxity in the joints. A score of zero indicates inflexible joints.
Time frame: baseline, 4 month visit
Secondary
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.
Time frame: baseline, 4 month visit
Secondary
Serum Relaxin Level
level of relaxin measured in each subject
Time frame: baseline, 4 month visit