Principal Investigator:
P.I.: Jolie Holschen, M.D. pager 14849
EM Faculty Contact:

Study Abstract (brief description, 3 - 5 sentences), including "short name of the study":
Ankle Injury
As female participation in athletics has increased, it has become apparent that a gender difference exists in the risk of sustaining musculoskeletal injuries. This study will evaluate whether there is a higher incidence of injury in ligamentous ankle injuries in women during hormonal surges at ovulation, and whether an anovulatory cycle or hormonal contraceptive use changes the risk period. Subjects will complete a questionnaire collecting demographic data, injury and menstrual history, and contraceptive use and provide 1 initial and 4 subsequent weekly urine samples. Subjects do not need to have injured their ankles during sports.

IRB# and approval date:
IRB #2005-0339, July 21, 2005

Study Start and End Dates:
Start Date: Mid-April, 2006 – until 66 subjects complete protocol

Inclusion criteria:

1. Acute ankle sprain of lateral ligaments per health care provider
2. Female
3. Age 15-30
4. Has had first menstrual period (post menarche)
5. Ottawa rules negative on health care provider’s assessment
   

Exclusion criteria:

1. No current physeal (growth plate) injury or fracture of the foot or ankle per health care provider
2. No previous ankle sprain or fracture on the currently affected side
3. No previous surgery on this foot or ankle
4. Not pregnant by history
5. Injury less than 24 hours ago
6. No significant trauma/force as cause (motor vehicle crash, fall >5 feet, hit by an object)
   

Names of staff working on study, including beeper and telephone number:

Jolie Holschen, MD, U of M Dept. of Emergency Medicine/Orthopaedic Surgery, Sports Medicine
Office phone: 930.7420 Pager: 14849

Study Coordinator: Barbara Smith, U of M Dept. of Emergency Medicine, Office phone: 936.4198, Pager: 3558


Will any test be charges to the study? If yes, please list and provide billing information.
No

Is the subject having tests and procedures done that will be relevant to their care in the ED or follow-up from the ED? If yes, what are the tests/procedures? Who will be responsible for interpreting those results and reporting them to the patient and , if appropriate, providing recommendations for follow-up?
No