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Metal on Metal Versus Ceramic on Metal Hip Replacement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00208494
First Posted: September 21, 2005
Last Update Posted: August 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DePuy Orthopaedics
Results First Submitted: July 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Non-inflammatory Joint Diseases
Interventions: Device: Total Hip Replacement
Device: Total hip replacement

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eleven sites enrolled 392 subjects who were then randomized into two groups. The investigational group, Ceramic-on-Metal (COM) and the control group, Metal-on-Metal (MOM). Two subjects were intraoperatively excluded, resulting in 194 subjects COM subjects and 196 MOM subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ceramic-on-Metal (COM) Total Hip Implant The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
Metal-on-Metal (MOM) Total Hip Implant The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.

Participant Flow:   Overall Study
    Ceramic-on-Metal (COM) Total Hip Implant   Metal-on-Metal (MOM) Total Hip Implant
STARTED   194   196 
COMPLETED   164   162 
NOT COMPLETED   30   34 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ceramic-on-Metal (COM) Total Hip Implant The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
Metal-on-Metal (MOM) Total Hip Implant The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
Total Total of all reporting groups

Baseline Measures
   Ceramic-on-Metal (COM) Total Hip Implant   Metal-on-Metal (MOM) Total Hip Implant   Total 
Overall Participants Analyzed 
[Units: Participants]
 194   196   390 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Age   58.9  (10.1)   59.1  (9.5)   59  (9.78) 
Gender 
[Units: Participants]
     
Female   83   91   174 
Male   111   105   216 
Region of Enrollment 
[Units: Participants]
     
United States   194   196   390 


  Outcome Measures

1.  Primary:   Composite Success/Failure   [ Time Frame: At 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jennifer Hoag, MS, Project Leader, Clinical Research
Organization: DePuy Orthopaedics, Inc.
phone: 574-372-7399
e-mail: JHoag2@its.jnj.com



Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00208494     History of Changes
Other Study ID Numbers: 03062
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: July 11, 2011
Results First Posted: August 4, 2011
Last Update Posted: August 14, 2013