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

NCT01481896 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2013-10-09

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

Metal-on-metal primary total hip arthroplasty (DePuy )

Replacement of a patient's native hip with an artificial implant featuring a metal-on-metal articulation

Sponsors & Collaborators

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • Anderson Orthopaedic Research Institute

    lead OTHER

Principal Investigators

  • Robert H Hopper, Jr., PhD · Anderson Orthopaedic Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481896 on ClinicalTrials.gov