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

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ClinicalTrials.gov Identifier: NCT01312532
Recruitment Status : Completed
First Posted : March 10, 2011
Last Update Posted : March 10, 2011
Sponsor:
Information provided by:
Isfahan University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: fixed-bearing (P.F.C.® Sigma) Device: mobile-bearing (P.F.C.® Sigma) Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Prosthesis in Total Knee Arthroplasty
Study Start Date : June 2004
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
fixed-bearing
fixed-bearing device is a kind of prosthesis
Device: fixed-bearing (P.F.C.® Sigma)
P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK
mobile-bearing
mobile-bearing device is a kind of prosthesis
Device: mobile-bearing (P.F.C.® Sigma)
P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK



Primary Outcome Measures :
  1. Knee Society Scoring [ Time Frame: five years after surgery ]
    was used for evaluating the function of the knee and high scores indicated better knee function


Secondary Outcome Measures :
  1. Pain [ Time Frame: five years after surgery ]
    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).



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with expected primary total knee arthroplasty

Exclusion Criteria:

  • Mediolateral instability
  • Infective arthritis
  • Severe deformity
  • Revision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312532


Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: mohammad dehghani, A.Professor Isfahan University of Medical Sciences

Additional Information:
Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01312532     History of Changes
Other Study ID Numbers: ASD-1213-17
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: June 2004

Keywords provided by Isfahan University of Medical Sciences:
Total knee arthroplasty
Fixed-bearing
Mobile-bearing

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases