CoMplete™ Acetabular Hip System

April 7, 2014 updated by: DePuy Orthopaedics

Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System

The primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective and prospective, non-randomized study of the Ceramic on Metal(CoM) device. This study will follow each subject through 10 years postoperatively. A total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new PAS subjects and approximately 100 subjects recruited from the investigational device exemption study to the PAS.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Hip and Knee Arkansas Foundation
    • California
      • Orange, California, United States, 92868
        • Orthopaedic Specialty Institute
    • Colorado
      • Ft. Collins, Colorado, United States, 80525
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
    • Ohio
      • Cincinnati, Ohio, United States, 45236
    • Washington
      • Seattle, Washington, United States, 98122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. If the subject:

    1. Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
    2. Qualifies based on the approved labeling for the device; and
  • 2. Is willing and able to provide informed patient consent for participation in the PAS study; and
  • 3. Is willing and able to return for follow-up as specified by the PAS study protocol; and

  • 4. Is willing and able to complete the hip outcomes questionnaire as specified by the PAS study protocol. A patient will be considered a "Valid Study Subject" when he/she has

    • consented to participate,
    • authorized release of Personal Health Information (PHI),
    • met all eligibility criteria through the operative stage, and
    • received the implant as noted in this protocol.

Exclusion Criteria:

  • Subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CoMplete™ Acetabular Hip System (CoM)
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
Device: Total hip replacement
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survivorship
Time Frame: 10 years
Subjects will be seen each year through year 5 postoperatively for radiographic and clinical follow-up, and then at 8 and 10 years postoperatively for radiographic and clinical follow-up. Survivorship means the removal of either or both of the components (ceramic head or metal liner).
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metal Ion Levels
Time Frame: 5 years, 8 years, and 10 years postoperatively
A subset of subjects will be measured for serum cobalt, serum chromium, erythrocytes cobalt, erythrocytes chromium, whole blood cobalt, and whole blood chromium levels. These subjects will also be measured for BUN and creatine levels.
5 years, 8 years, and 10 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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