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
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 April 17, 2014