Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia

This study has been terminated.
(The study sponsor canceled the study.)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00579059
First received: December 17, 2007
Last updated: February 29, 2012
Last verified: February 2012
Results First Received: May 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Interventions: Device: Maxim® Knee System with Removable Molded Polyethylene Tibia
Device: Regular Maxim® Knee System

  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 recruited by the investigator.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no pre-assignment details to report.

Reporting Groups
  Description
Maxim® Pop-Top® Tibia tibia with removable polyethylene
Maxim® Regular Tibia Tibia with Modular Polyethylene

Participant Flow:   Overall Study
    Maxim® Pop-Top® Tibia     Maxim® Regular Tibia  
STARTED     21 [1]   10 [1]
Immediate Post-Op     20 [2]   9 [2]
6 Months     11 [3]   4 [4]
1 Year     8 [5]   3 [6]
3 Years     0 [7]   0 [7]
5 Years     0 [7]   0 [7]
COMPLETED     0 [8]   0 [8]
NOT COMPLETED     21     10  
Study Canceled at 1 Year                 21                 10  
[1] Enrollment was incomplete due to study cancellation.
[2] 1 Patient didn't return for follow-up.
[3] 10 Patients didn't return for follow-up.
[4] 6 patients didn't return for follow-up.
[5] 13 patients didn't return for follow-up.
[6] 7 patients didn't return for follow-up.
[7] Incomplete due to study closure at 1-year of follow-up.
[8] No Patients completed through 5 years due to study closure at 1-year of follow-up.



  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
Maxim® Pop-Top® Tibia tibia with removable polyethylene
Maxim® Regular Tibia Tibia with Modular Polyethylene
Total Total of all reporting groups

Baseline Measures
    Maxim® Pop-Top® Tibia     Maxim® Regular Tibia     Total  
Number of Participants  
[units: participants]
  21     10     31  
Age  
[units: years]
Mean ( Full Range )
  68  
  ( 53 to 82 )  
  62  
  ( 54 to 75 )  
  65  
  ( 53 to 82 )  
Gender  
[units: participants]
     
Female     17     5     22  
Male     4     5     9  
Region of Enrollment  
[units: participants]
     
United States     21     10     31  



  Outcome Measures
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1.  Primary:   Knee Society Function Score   [ Time Frame: 1 Year ]

2.  Secondary:   Range of Motion - Flexion   [ Time Frame: 1 Year ]


  Serious Adverse Events


  Other Adverse Events


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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
Study was terminated after enrollment failed to produce sufficient data to be analyzed.  


Results Point of Contact:  
Name/Title: Megan Lawson, Clinical Research Specialist
Organization: Biomet, LLC
phone: 1-800-348-9500 ext 1183
e-mail: megan.lawson@biomet.com


No publications provided


Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00579059     History of Changes
Other Study ID Numbers: 62-U-007
Study First Received: December 17, 2007
Results First Received: May 20, 2009
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board