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Completed

NCT Number: NCT01312532

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

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-zahra university hospital

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with expected primary total knee arthroplasty

Exclusion criteria

  • Mediolateral instability
  • Infective arthritis
  • Severe deformity
  • Revision

Treatment and study plan

fixed-bearing (P.F.C.® Sigma)

Device

P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK

mobile-bearing (P.F.C.® Sigma)

Device

P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Study of Prosthesis in Total Knee Arthroplasty

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Mar 10, 2011
Registry last updated
Mar 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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