Acetabular Bone Vascularity in Metal-on-Metal Revisions

Stopped early

Conditions studied: Failure of Total Hip

In brief

The purpose of this study is to determine if avascular necrosis of the acetabulum is present in metal-on-metal revisions and to what depth this dead avascular bone occurs. A convenient sample of a consecutive series of 15 patients treated for metal on metal acetabular revision surgery will be included.

Key facts

Study ID

NCT02239406

Run by

OrthoCarolina Research Institute, Inc.

People needed

7

Starts

2014-11-01

Expected to finish

2016-04-01

Last updated by the study team

2016-07-22

Who can join

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

You may qualify if…

• Patients being revised for an aseptic metal on metal acetabular revision.
• Patient is greater than one year postoperative.
• Patient has had cobalt and chromium metal ion levels tested within 6 months of the planned revision surgery.
• Understands the local language and is willing and able to follow the requirements of the protocol.
• Understands the informed consent and signs the institutional review board or independent ethics committee (IRB/IEC) approved informed consent form.

You may not qualify if…

• History of infection
• Evidence of current substance or alcohol abuse
• Being treated with radiation, chemotherapy, immunosupression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)
• Is a prisoner

Where it is running

• OrthoCarolina — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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