Institutional Review Board, Hospital for Special Surgery
November 07, 2013
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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-trunnion junction, 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.
• Patients with revision THA
Chitranjan S. Ranawat, MD