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Blood Metal Ions Level in Patients with Large Sized Ceramic or Metal Head Total Hip Arthroplasty

IRB Number: 13050
(inactive trial)

Institutional Review Board, Hospital for Special Surgery

November 07, 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.

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Principal Investigator

Chitranjan S. Ranawat, MD


Amar S. Ranawat, MD
Sarah West
Matin Lendhey


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

Inclusion/Exclusion Criteria

Inclusion Criteria:
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.
Exclusion Criteria:
• Patients with revision THA

Contact Information

Chitranjan S. Ranawat, MD