Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Change of anterior tibial translation of the knee with progestin-only hormonal contraception
研究概览
简要总结
Women are recognized as being at greater risk of ACL injury, with a risk 6 times higher than that of men. Hyperlaxity is a risk factor for ACL injury, but the pathophysiological basis for this is poorly studied. Hormonal impregnation and certain periods of the menstrual cycle (ovulatory phase) are risk factors for ACL injury. It therefore seems interesting to study the influence of hormonal impregnation on ligament laxity. To date, to our knowledge, no study has investigated such a relationship.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female between 18 and 40 years of age;
- •No history of surgery on the 2 lower limbs;
- •No change in contraceptive method in the last 6 months;
- •Signature of informed consent ;
- •Social security affiliation;
- •D14 of her menstrual cycle (+/-1 day) (the first day of the cycle (D1) being considered as the first day of menstruation), except for those on unregulated micro-progestogen contraception.
排除标准
- •Pregnancy or breastfeeding (check with urine pregnancy test);
- •Menopause;
- •Surgery: tubal ligation, oophorectomy, adnexectomy, hysterectomy;
- •History of inflammatory joint disease, systemic or localized to the knee;
- •History of microcrystalline or infectious pathology localized to the knee;
- •History of fracture, severe sprain or dislocation of the knee joint;
- •History of osteoarticular or congenital diseases that may lead to ACL laxity (e.g. Marfan syndrome, trisomy 21, Ehlers-Danlos syndrome, etc.);
- •Signs of hyperlaxity (Beighton test > 4);
- •BMI > 25 ;
- •Daily alcohol consumption above the thresholds recommended by Public Health in France (more than 2 glasses per day);
- •Intense or unusual physical exercise during the last 72 hours before the inclusion visit;
- •Inability to understand the protocol;
- •Women under guardianship, curatorship or deprived of liberty.
研究组 & 干预措施
Group 1 Women on estrogen-progestin contraception
For women on estrogen-progestin contraception:
- Correct use of the estrogen-progestin pill in accordance with AMM Or wearing a vaginal ring according to AMM protocol Or wearing a contraceptive skin patch according to AMM protocol
- Regular cycles of 26 to 33 days
干预措施: Beighton test (Other)
Group 1 Women on estrogen-progestin contraception
For women on estrogen-progestin contraception:
- Correct use of the estrogen-progestin pill in accordance with AMM Or wearing a vaginal ring according to AMM protocol Or wearing a contraceptive skin patch according to AMM protocol
- Regular cycles of 26 to 33 days
干预措施: Lachman Test (Other)
Group 2 Women on progestogen contraception
For women on progestin-only contraception:
o Continuous use of the micro-progestogen or progestogen pill Or subcutaneous hormonal implant, Or a progesterone intrauterine device Or dienogest-type contraception
干预措施: Questionnaire (Other)
Group 2 Women on progestogen contraception
For women on progestin-only contraception:
o Continuous use of the micro-progestogen or progestogen pill Or subcutaneous hormonal implant, Or a progesterone intrauterine device Or dienogest-type contraception
干预措施: Lachman Test (Other)
Group 3 Women without hormonal contraception
For women without hormonal contraception :
- No method of contraception Or copper intrauterine device
- Regular cycles of 26 to 33 days
干预措施: Questionnaire (Other)
Group 3 Women without hormonal contraception
For women without hormonal contraception :
- No method of contraception Or copper intrauterine device
- Regular cycles of 26 to 33 days
干预措施: Beighton test (Other)
Group 3 Women without hormonal contraception
For women without hormonal contraception :
- No method of contraception Or copper intrauterine device
- Regular cycles of 26 to 33 days
干预措施: Lachman Test (Other)
Group 1 Women on estrogen-progestin contraception
For women on estrogen-progestin contraception:
- Correct use of the estrogen-progestin pill in accordance with AMM Or wearing a vaginal ring according to AMM protocol Or wearing a contraceptive skin patch according to AMM protocol
- Regular cycles of 26 to 33 days
干预措施: Questionnaire (Other)
Group 2 Women on progestogen contraception
For women on progestin-only contraception:
o Continuous use of the micro-progestogen or progestogen pill Or subcutaneous hormonal implant, Or a progesterone intrauterine device Or dienogest-type contraception
干预措施: Beighton test (Other)
结局指标
主要结局
Change of anterior tibial translation of the knee with progestin-only hormonal contraception
时间窗: 24 months
To show that taking progestin-only hormonal contraception reduces anterior tibial translation of the knee compared with other types of contraception. Anterior tibial knee translation will be considered representative of anterior knee laxity in women on hormonal contraception, using the 30° Lachman test measured with a Lachmeter® digital arthrometer (bilateral examination repeated 3 times on each knee). The degree of laxity is assessed using the international IKDC classification: * Grade A 0 to 2 mm = normal * Grade B 3 to 5 mm = almost normal * Grade C 6 to 10 mm = abnormal * Grade D \> 10 mm = severely abnormal
次要结局
- Anterior knee laxity at D14 and D25 of the cycle(14 or 25 days)
- Variable of weight influencing anterior tibial knee translation(24 months)
- Change of anterior tibial translation of the knee with progestin-only hormonal contraception or estrogen-only contraception.(24 months)
- Variable of age influencing anterior tibial knee translation(24 months)
- Variable of cycle lenght influencing anterior tibial knee translation(24 months)
- Variable of height influencing anterior tibial knee translation(24 months)
- Variable of duration of contraceptive use influencing anterior tibial knee translation(24 months)