Institutional Review Board, Hospital for Special Surgery
June 10, 2010
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 study prospectively enrolls pediatric patients with acute avulsion of the medial epicondyle treated with operative and non-operative means and follows daily function and athletic function as well as radiographic outcomes, symptomatic outcomes, and physical exam.
Patients between the ages of 9 and 18 who experience an acute onset of elbow pain with radiographic evidence of avulsion fracture of the medial epicondyle will be included in our study.
Our study will exclude the following patients: patients over the age of 18, and patients with prior surgery or injury to the ipsilateral extremity.
Daniel W. Green, MD