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A Study to Compare the NexGen LPS and LPS-Flex Knee Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00763386
First received: September 26, 2008
Last updated: May 25, 2012
Last verified: May 2012
Results First Received: December 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Total Knee Arthroplasty
Osteoarthritis
Interventions: Device: NexGen LPS-Flex Fixed Bearing Knee
Device: NexGen Legacy Posterior Stabilized Knee

  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 enrolled between June 2001 and December 2007 at a total of 12 sites throughout the US/Canada

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
LPS Flex Fixed Bearing Knee Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
LPS Standard Knee Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.

Participant Flow:   Overall Study
    LPS Flex Fixed Bearing Knee     LPS Standard Knee  
STARTED     164     167  
COMPLETED     116     127  
NOT COMPLETED     48     40  
Adverse Event                 43                 33  
Death                 1                 2  
Lost to Follow-up                 3                 3  
Withdrawal by Subject                 0                 1  
CRF missing                 0                 1  
Study Prosthesis Removed                 1                 0  



  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
LPS Flex Fixed Bearing Knee Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
LPS Standard Knee Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
Total Total of all reporting groups

Baseline Measures
    LPS Flex Fixed Bearing Knee     LPS Standard Knee     Total  
Number of Participants  
[units: participants]
  164     167     331  
Age [1]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     83     82     165  
>=65 years     81     84     165  
Age [1]
[units: years]
Mean ± Standard Deviation
  64.6  ± 8.1     64.9  ± 8.4     64.7  ± 8.3  
Gender [1]
[units: participants]
     
Female     92     84     176  
Male     72     82     154  
Region of Enrollment  
[units: participants]
     
United States     133     138     271  
Canada     31     29     60  
[1] An LPS Standard patient's demographic CRF is missing and therefore, the total numbers for this category will be off by one.



  Outcome Measures
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1.  Primary:   Postoperative Range of Motion (ROM)   [ Time Frame: 6 Weeks to 2 Years Post-op, based on on the intervals listed ]

2.  Secondary:   Return to Function (RtF) Via Knee Society Score (Modified)   [ Time Frame: 6 Weeks to 2 Years Post-op, based on on the intervals listed ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Kacy Arnold, Associate Director, Clinical Affairs
Organization: Zimmer
phone: 574-371-8336
e-mail: kacy.arnold@zimmer.com


No publications provided


Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT00763386     History of Changes
Other Study ID Numbers: 00-500
Study First Received: September 26, 2008
Results First Received: December 13, 2011
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board