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Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00561600
First received: November 20, 2007
Last updated: April 7, 2014
Last verified: April 2014
Results First Received: February 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Non-inflammatory Degenerative Joint Disease
Interventions: Device: ASR™-XL Modular Acetabular Cup System
Device: Pinnacle™ acetabular shell

  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
Recruitment at orthopaedic clinics began Nov 2006 and ended Dec 2009

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
A ASR™-XL ASR™-XL Modular Acetabular Cup System stem
B Pinnacle™ Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.

Participant Flow:   Overall Study
    A ASR™-XL     B Pinnacle™  
STARTED     130     135  
COMPLETED     112     119  
NOT COMPLETED     18     16  



  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
ASR XL ASR™-XL Acetabular Cup System
Pinnacle MoM Pinnacle metal on metal acetabular cup system
Total Total of all reporting groups

Baseline Measures
    ASR XL     Pinnacle MoM     Total  
Number of Participants  
[units: participants]
  130     135     265  
Age  
[units: years]
Mean ± Standard Deviation
  59.7  ± 8.6     59.4  ± 9.4     59.6  ± 9.0  
Gender  
[units: participants]
     
Female     60     51     111  
Male     70     84     154  
Region of Enrollment  
[units: participants]
     
United States     130     135     265  
BMI [1]
[units: lb/in^2]
Mean ± Standard Deviation
  29.7  ± 7.0     30.1  ± 6.0     29.9  ± 6.5  
[1] Body mass index



  Outcome Measures
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1.  Primary:   Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes   [ Time Frame: 24-month interval. ]

2.  Secondary:   T-Test of Harris Hip Total Score Means at 24 Months   [ Time Frame: 24 months ]

3.  Secondary:   Harris Hip Pain Sub Score at 24 Months   [ Time Frame: 24 months ]

4.  Secondary:   Harris Hip Function Score at 24 Months   [ Time Frame: 24 months ]

5.  Secondary:   Analysis of Metal Ion Release - Serum Cobalt   [ Time Frame: Pre-operative ]

6.  Secondary:   Analysis of Metal Ion Release - Serum Chromium   [ Time Frame: pre-operative ]

7.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Cobalt   [ Time Frame: pre-operative ]

8.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Chromium   [ Time Frame: Pre-operative ]

9.  Secondary:   Analysis of Metal Ion Release - Serum Cobalt   [ Time Frame: 4 months post-operative ]

10.  Secondary:   Analysis of Metal Ion Release - Serum Chromium   [ Time Frame: 4 months post operative ]

11.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Cobalt   [ Time Frame: 4 months post-operative ]

12.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Chromium   [ Time Frame: 4 months post-operative ]

13.  Secondary:   Analysis of Metal Ion Release - Serum Cobalt   [ Time Frame: 12 months post-operative ]

14.  Secondary:   Analysis of Metal Ion Release - Serum Chromium   [ Time Frame: 12 Months ]

15.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Cobalt   [ Time Frame: 12 Months ]

16.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Chromium   [ Time Frame: 12 months ]

17.  Secondary:   Analysis of Metal Ion Release - Serum Cobalt   [ Time Frame: 24 months ]

18.  Secondary:   Analysis of Metal Ion Release - Serum Chromium   [ Time Frame: 24 months ]

19.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Cobalt   [ Time Frame: 24 months ]

20.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Chromium   [ Time Frame: 24 months ]

21.  Secondary:   Analysis of Metal Ion Release - Serum Cobalt   [ Time Frame: 36 months ]

22.  Secondary:   Analysis of Metal Ion Release - Serum Chromium   [ Time Frame: 36 months ]

23.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Cobalt   [ Time Frame: 36 months ]

24.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Chromium   [ Time Frame: 36 months ]

25.  Secondary:   Analysis of Metal Ion Release - Serum Cobalt   [ Time Frame: 48 months ]

26.  Secondary:   Analysis of Metal Ion Release - Serum Chromium   [ Time Frame: 48 months ]

27.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Cobalt   [ Time Frame: 48 months ]

28.  Secondary:   Analysis of Metal Ion Release - Erythrocyte Chromium   [ Time Frame: 48 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.


  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: Dave Whalen Clinical Portfolio Leader
Organization: DePuy Orthopaedics
phone: 574-372-7028
e-mail: dwhalen@its.jnj.com


No publications provided


Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00561600     History of Changes
Other Study ID Numbers: 04062
Study First Received: November 20, 2007
Results First Received: February 5, 2014
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board