Institutional Review Board, Hospital for Special Surgery
November 13, 2009
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.
As subject population will be determined via retrospective chart review, we are not actively recruiting subjects.
Data will be collected by the co-investigators through a retrospective chart review
of all patients with elbow flexion deformities secondary to cerebral palsy, who
have undergone corrective elbow surgery performed by the primary investigator.
Specifically, outcomes of fractional lengthening and full elbow release procedures
will be investigated. Pre and post-operative elbow range of motion, angle during
ambulation will be compared.
N/A – we are not actively recruiting subjects.
Krystle Hearns MA,
Co-Director of Research, CHArm Center