Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01312532
First received: March 9, 2011
Last updated: NA
Last verified: June 2004
History: No changes posted

March 9, 2011
March 9, 2011
June 2004
November 2010   (final data collection date for primary outcome measure)
Knee Society Scoring [ Time Frame: five years after surgery ] [ Designated as safety issue: Yes ]
was used for evaluating the function of the knee and high scores indicated better knee function
Same as current
No Changes Posted
Pain [ Time Frame: five years after surgery ] [ Designated as safety issue: Yes ]
Pain was evaluated with a Visual Analogue Scale (VAS) with scores ranging from zero to 10ten (0 for no pain and 10 for intolerable pain).
Same as current
Not Provided
Not Provided
 
Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial
Study of Prosthesis in Total Knee Arthroplasty

The purpose of this study is to determine which prosthesis is better in total knee arthroplasty

Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Device: fixed-bearing (P.F.C.® Sigma)
    P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK
  • Device: mobile-bearing (P.F.C.® Sigma)
    P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK
  • fixed-bearing
    fixed-bearing device is a kind of prosthesis
    Intervention: Device: fixed-bearing (P.F.C.® Sigma)
  • mobile-bearing
    mobile-bearing device is a kind of prosthesis
    Intervention: Device: mobile-bearing (P.F.C.® Sigma)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with expected primary total knee arthroplasty

Exclusion Criteria:

  • Mediolateral instability
  • Infective arthritis
  • Severe deformity
  • Revision
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01312532
ASD-1213-17
Yes
Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Not Provided
Study Chair: mohammad dehghani, A.Professor Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
June 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP