Institutional Review Board, Hospital for Special Surgery
June 03, 2008
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
This investigation requires only one visit, which is expected to last about 90 minutes. Our study subjects will first stand and then walk across a special sensor that registers footprints. We will then apply small foam rubber pads to specific foot locations and will ask the subjects to stand and work across the sensor again. After this, the subjects will have foot X-rays taken with the pads still attached, which will end the study visit.
We are seeking to enroll 10 healthy males and females, between the ages of 18 and 65, with normally aligned feet.
If any of the following applies to you, you can not be in this study:
• If you have any history of foot trauma or surgery
• If you have any history of hip or knee trauma or surgery
• If you have recurrent foot pain
• If you have flat or excessively high-arched feet.
• If you are a patient of Dr. Deland