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36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00953719
First received: June 3, 2009
Last updated: August 19, 2014
Last verified: August 2014
Results First Received: May 13, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-inflammatory Degenerative Joint Disease
Interventions: Device: 36 mm ceramic head on a ceramic acetabular liner
Device: 28 mm ceramic head on a polyethylene acetabular liner

  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
Patients were selected for recruitment into the study from the general diagnosis population defined as “primary total hip arthroplasty (THA) for non-inflammatory degenerative joint disease (NIDJD).” The investigation was conducted at 5 centers. The same inclusion and exclusion criteria applied to both investigational and control groups.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the Adverse Event data reported, but the subject was not included in the the number of participants because there are no follow-up data on this subject outside of operative details.

Reporting Groups
  Description
36 mm Ceramic-on-ceramic

36 mm ceramic head on ceramic acetabular liner

36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner

28 mm Ceramic-on-polyethylene

28 mm ceramic-on-polyethylene historical control

28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.


Participant Flow:   Overall Study
    36 mm Ceramic-on-ceramic     28 mm Ceramic-on-polyethylene  
STARTED     169     74  
COMPLETED     150     69  
NOT COMPLETED     19     5  



  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.
The baseline analysis population consists of all enrolled subjects who were implanted with either the investigational or control device. One subject who was randomized to receive the investigational device was exlcuded because of an intra-operative ceramic liner fracture, and hence did not receive the investigational device.

Reporting Groups
  Description
36 mm Ceramic-on-ceramic

36 mm ceramic head on ceramic acetabular liner

36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner

28 mm Ceramic-on-polyethylene

28 mm ceramic-on-polyethylene historical control

28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.

Total Total of all reporting groups

Baseline Measures
    36 mm Ceramic-on-ceramic     28 mm Ceramic-on-polyethylene     Total  
Number of Participants  
[units: participants]
  168     74     242  
Age  
[units: years]
Mean ± Standard Deviation
  57.3  ± 11.0     56.9  ± 9.7     57.2  ± 10.6  
Gender  
[units: participants]
     
Female     76     27     103  
Male     92     47     139  
Region of Enrollment  
[units: participants]
     
United States     168     74     242  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Harris Hip Score   [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]

2.  Secondary:   Harris Hip Subscale Score: Pain   [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]

3.  Secondary:   Harris Hip Subscale Score: Function   [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]

4.  Secondary:   Harris Hip Subscale Score: Activities   [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]

5.  Secondary:   Harris Hip Subscale Score: Deformity   [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]

6.  Secondary:   Harris Hip Subscale Score: Range of Motion   [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]

7.  Secondary:   Harris Hip Score Longitudinal Analysis   [ Time Frame: 6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively ]

8.  Secondary:   Proportion of Composite Successes   [ Time Frame: At final follow-up visit, 24 months or later, up to 72 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
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study.


  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: Sam Himden
Organization: DePuy Orthopaedics, Inc.
phone: 574-372-7231
e-mail: shimden@its.jnj.com


No publications provided


Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00953719     History of Changes
Other Study ID Numbers: COC 36 mm
Study First Received: June 3, 2009
Results First Received: May 13, 2014
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration