A Five-Year Metal-on-Metal Retrospective Clinical Study

Completed

Conditions studied: Osteoarthritis

In brief

This retrospective study will review the Anderson Orthopaedic Institute's initial experience among a consecutive series of 126 patients who had primary total hip arthroplasty using a metal-on-metal articulation consisting of a DePuy Pinnacle cup with an Ultamet liner coupled with a 36-mm cobalt-chrome alloy femoral head. The relationship between metal ion levels, cup orientation, osteolysis, radiographic implant stability and clinical outcome measures including component revision, complications, patient satisfaction and Harris Hip Scores will be evaluated.

Key facts

Study ID

NCT01481896

Run by

Anderson Orthopaedic Research Institute

People needed

126

Starts

2011-12-01

Expected to finish

2012-06-01

Last updated by the study team

2013-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary total hip arthroplasty patients who had surgery between April 2001 and November 2002 who were implanted with a Pinnacle acetabular cup, an Ultamet metal-on-metal insert and a 36mm cobalt-chrome alloy femoral head

You may not qualify if…

• Revision total hip arthroplasties
• Primary total hip arthroplasties using Ultamet liners coupled with 28-mm femoral heads

Where it is running

• Anderson Orthopaedic Research Institute — Alexandria, Virginia, United States

Full record on ClinicalTrials.gov

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