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Metal on Metal Versus Ceramic on Metal Hip Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00208494
First received: September 13, 2005
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
Results First Received: July 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: 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
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.

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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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  
Number of Participants  
[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 ]
  Show Outcome Measure 1

2.  Secondary:   Harris Hip Score   [ Time Frame: Pre-operative, 4 weeks, 3 months and 1, 2, 3 and 4 years. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Complication Rates   [ Time Frame: On-going to end of study. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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


No publications provided


Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00208494     History of Changes
Other Study ID Numbers: 03062
Study First Received: September 13, 2005
Results First Received: July 11, 2011
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration