Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial
Phase 2
Completed
- Conditions
- Osteoarthritis
- Interventions
- Device: fixed-bearing (P.F.C.® Sigma)Device: mobile-bearing (P.F.C.® Sigma)
- Registration Number
- NCT01312532
- Lead Sponsor
- Isfahan University of Medical Sciences
- Brief Summary
The purpose of this study is to determine which prosthesis is better in total knee arthroplasty
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Patients with expected primary total knee arthroplasty
Exclusion Criteria
- Mediolateral instability
- Infective arthritis
- Severe deformity
- Revision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description fixed-bearing fixed-bearing (P.F.C.® Sigma) fixed-bearing device is a kind of prosthesis mobile-bearing mobile-bearing (P.F.C.® Sigma) mobile-bearing device is a kind of prosthesis
- Primary Outcome Measures
Name Time Method Knee Society Scoring five years after surgery was used for evaluating the function of the knee and high scores indicated better knee function
- Secondary Outcome Measures
Name Time Method Pain 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).
Trial Locations
- Locations (1)
Al-zahra university hospital
🇮🇷Isfahan, Iran, Islamic Republic of