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Metal on Metal Versus Ceramic on Metal Hip Replacement

NCT00208494 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2013-08-14

Study results available
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Summary

The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up). Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.

Conditions

  • Non-inflammatory Joint Diseases

Interventions

DEVICE

Total Hip Replacement

Total hip replacement

DEVICE

Total hip replacement

Total hip replacement

Sponsors & Collaborators

  • DePuy Orthopaedics

    lead INDUSTRY

Principal Investigators

  • David Scott, MD · Orthopaedic Specialty Clinic

  • Patrick G Kirk, MD

  • Shekhar S Desai, MD

  • Charles A Engh, Jr., MD · Anderson Clinic

  • Ajai Cadambi, MD · Adult Orthopaedic Reconstruction Texas Hip and Knee Center

  • C L Barnes, MD · Foundation for Musculoskeletal Research & Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-12-31
Completion
2011-06-30

Countries

  • United States
  • Canada

Study Locations

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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 NCT00208494 on ClinicalTrials.gov