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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Prosthesis in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Enrollment: 100
Study Start Date: June 2004
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with expected primary total knee arthroplasty

Exclusion Criteria:

  • Mediolateral instability
  • Infective arthritis
  • Severe deformity
  • Revision
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: March 9, 2011
Last Updated: March 9, 2011
Health Authority: Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on September 16, 2014