Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

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. Identifier: NCT01027819
Recruitment Status : Unknown
Verified December 2012 by Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 9, 2009
Results First Posted : April 5, 2011
Last Update Posted : December 20, 2012
Information provided by (Responsible Party):
Seoul National University Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoarthritis of Knee
Interventions: Device: Mobile bearing
Device: Fixed bearing

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was started from Sep 2005 to Aug 2006 in medical clinic and randomly allocated into two groups.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Mobile Bearing Mobile bearing vs Fixed bearing
Fixed Bearing Mobile bearing vs Fixed bearing

Participant Flow:   Overall Study
    Mobile Bearing   Fixed Bearing
STARTED   40   40 
COMPLETED   40   40 

  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
Mobile Bearing Mobile bearing vs Fixed bearing
Fixed Bearing Mobile bearing vs Fixed bearing
Total Total of all reporting groups

Baseline Measures
   Mobile Bearing   Fixed Bearing   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   9   17   26 
>=65 years   31   23   54 
[Units: Years]
Mean (Standard Deviation)
 68.36  (5.61)   66.08  (5.55)   67.24  (5.81) 
[Units: Participants]
Female   2   1   3 
Male   38   39   77 
Region of Enrollment 
[Units: Participants]
Korea, Republic of   40   40   80 

  Outcome Measures

1.  Primary:   Rotational Angle Between Femur and Tibia   [ Time Frame: 2 weeks ]

2.  Secondary:   Knee Society Score   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  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

First, our study population is composed of elderly patients with large female dominance

Second concern was inherent errors in making the measurements in this kind of study

  More Information

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: Dr. Dongwook Kim
Organization: Seoul National University Hospital
phone: 821067395311

Responsible Party: Seoul National University Hospital Identifier: NCT01027819     History of Changes
Other Study ID Numbers: SNUHOSK09MBFB
SNUHOSK09MBFB ( Other Identifier: Seoul national university hospital )
First Submitted: December 7, 2009
First Posted: December 9, 2009
Results First Submitted: March 6, 2011
Results First Posted: April 5, 2011
Last Update Posted: December 20, 2012