Osteoarthritis
Conditions
Keywords
Total knee arthroplasty, Fixed-bearing, Mobile-bearing
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.
Interventions
DEVICEfixed-bearing (P.F.C.® Sigma)
P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK
DEVICEmobile-bearing (P.F.C.® Sigma)
P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients with expected primary total knee arthroplasty
Exclusion criteria
* Mediolateral instability * Infective arthritis * Severe deformity * Revision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Scoring | five years after surgery | was used for evaluating the function of the knee and high scores indicated better knee function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Iran
Outcome results
None listed