Institutional Review Board, Hospital for Special Surgery
June 26, 2013
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.
Amar S. Ranawat, MD
The research question is, is there a statistically significant difference between blood metal ions, emerging from head-trunnionjunction, in these two (large ceramic head and large metal head) groups?
Large ceramic heads: Study group
Large metal heads: Control group
We hypothesize that there is no difference between these groups. In other words, we expect no metal ions from the head-trunnion junction in either of these groups. Answering this question will shed light on large sized head type (either ceramic or metal) that is safe.
In this study, we will include 60 patients with 5 year follow-up
a. Patients who received either large sized (32 or 36mm) ceramic head on highly cross-linked polyethylene (HXLPE) bearing (Cases) or received large sized (36mm) metal head on HXLPE bearing (Control) during THA.
b. Patients above 18 years old
c. All patients will be within the same post-op time frame (5 year post-op) and that ion levels will be tested 5 years post index surgery on all patients.
Chitranjan S. Ranawat, MD