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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01027819
First received: December 7, 2009
Last updated: December 13, 2012
Last verified: December 2012
Results First Received: March 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoarthritis of Knee
Interventions: Device: Mobile bearing
Device: Fixed bearing

  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
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
  Description
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  
NOT COMPLETED     0     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
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  
Number of Participants  
[units: participants]
  40     40     80  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     17     26  
>=65 years     31     23     54  
Age  
[units: years]
Mean ± Standard Deviation
  68.36  ± 5.61     66.08  ± 5.55     67.24  ± 5.81  
Gender  
[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.   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

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
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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: Dr. Dongwook Kim
Organization: Seoul National University Hospital
phone: 821067395311
e-mail: daljookim@gmail.com


No publications provided


Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01027819     History of Changes
Other Study ID Numbers: SNUHOSK09MBFB, SNUHOSK09MBFB
Study First Received: December 7, 2009
Results First Received: March 6, 2011
Last Updated: December 13, 2012
Health Authority: Korea: Institutional Review Board