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Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00289094
First received: February 7, 2006
Last updated: August 6, 2013
Last verified: August 2013
Results First Received: September 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Juvenile Rheumatoid Arthritis
Avascular Necrosis of Bone
Interventions: Device: Total Knee Replacement
Device: Total knee 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
Two US clinical centers performed 99 primary knee replacements in 86 subjects. Recruitment was based on the inclusion and exclusion criteria as specified in the clinical investigation plan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Immediately before surgery, the implant type was determined according to the randomization schedule. Before treatment assignment, consented subjects could be excluded from the trial based on results of pre-operative clinical evaluations and/or radiographs, as per the exclusion criteria in the CIP.

Reporting Groups
  Description
Rotating Platform P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
Fixed Bearing P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.

Participant Flow:   Overall Study
    Rotating Platform     Fixed Bearing  
STARTED     50     49  
COMPLETED     3     2  
NOT COMPLETED     47     47  



  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
Rotating Platform P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
Fixed Bearing P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
Total Total of all reporting groups

Baseline Measures
    Rotating Platform     Fixed Bearing     Total  
Number of Participants  
[units: participants]
  50     49     99  
Age  
[units: years]
Mean ± Standard Deviation
  63.7  ± 6.2     66.9  ± 5.1     65.3  ± 5.9  
Gender  
[units: participants]
     
Female     31     26     57  
Male     19     23     42  
Region of Enrollment  
[units: participants]
     
United States     50     49     99  



  Outcome Measures

1.  Primary:   Knee Society Scores   [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ]

2.  Secondary:   Complications/Revisions   [ Time Frame: On-going to end of study. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Medical Imaging   [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   SF-12 Patient Outcomes   [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Tammy O'Dell, EMT, CCRA
Organization: DePuy Orthopaedics, Inc.
phone: 574-372-7104
e-mail: TOdell2@its.jnj.com


No publications provided


Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00289094     History of Changes
Other Study ID Numbers: SRP-2
Study First Received: February 7, 2006
Results First Received: September 29, 2010
Last Updated: August 6, 2013
Health Authority: United States: Food and Drug Administration