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Trial record 146 of 179 for:    "Arthritis, Juvenile Rheumatoid"

Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00487565
Recruitment Status : Completed
First Posted : June 18, 2007
Results First Posted : March 23, 2012
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Juvenile Arthritis
Intervention: Device: Total knee arthroplasty

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between September 2006 and February 2011, 210 subjects were recruited and enrolled at 4 clinics by orthopaedic surgeons. Recruitment was based on the inclusion and exclusion criteria in the clinical investigation plan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a non-randomized study so all subjects that met the inclusion/exclusion criteria received the LCS Complete Posterior Stabilized implant. Consented subjects could be excluded from the trial based on results of pre-operative clinical and/or radiographic evaluations, as per the exclusion criteria in the clinical investigation plan.

Reporting Groups
  Description
LCS Complete Posterior Stabilized Knee Implant Total knee arthroplasty with a posterior stabilized implant

Participant Flow:   Overall Study
    LCS Complete Posterior Stabilized Knee Implant
STARTED   210 
COMPLETED   182 
NOT COMPLETED   28 



  Baseline Characteristics

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
LCS Complete Posterior Stabilized Knee Implant Total knee arthroplasty with a posterior stabilized implant

Baseline Measures
   LCS Complete Posterior Stabilized Knee Implant 
Overall Participants Analyzed 
[Units: Participants]
 210 
Age 
[Units: Participants]
Mean (Standard Deviation)
 
Age   63.8  (9.8) 
Gender 
[Units: Participants]
 
Female   120 
Male   90 
Region of Enrollment 
[Units: Participants]
 
United States   180 
Switzerland   30 


  Outcome Measures

1.  Primary:   Knee Active Flexion   [ Time Frame: 12 month ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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
Organization: DePuy Orthopaedics, Inc.
phone: 574-372-7104
e-mail: TOdell2@its.jnj.com



Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00487565     History of Changes
Other Study ID Numbers: 06005
LCS:PS
First Submitted: June 14, 2007
First Posted: June 18, 2007
Results First Submitted: February 21, 2012
Results First Posted: March 23, 2012
Last Update Posted: August 14, 2013