Institutional Review Board, Hospital for Special Surgery
November 05, 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.
We plan to perform MRI scans of 50 subjects. Enrollment period will start once the scanning protocol has been approved by the IRB and has been verified with quality control scans of a phantom. The subject will be enrolled in the study for the duration of the scanning session.
Referring physician request for diagnostic evaluation of joint arthroplasty or other orthopedic instrumentation in an adult patient.
Patients with absolute contraindications to MRI, patients unable to give informed consent, children under the age of 18 years.
Matthew Koff, Ph.D.