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

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Device: fixed-bearing (P.F.C.® Sigma); Device: mobile-bearing (P.F.C.® Sigma)

Study type: Interventional

Funder types: Other

Identifiers

NCT01312532

ASD-1213-17

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with expected primary total knee arthroplasty

Exclusion criteria

• Mediolateral instability
• Infective arthritis
• Severe deformity
• Revision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

fixed-bearing

Other group

Description:

fixed-bearing device is a kind of prosthesis

Treatment:

Device: fixed-bearing (P.F.C.® Sigma)

mobile-bearing

Other group

Description:

mobile-bearing device is a kind of prosthesis

Treatment:

Device: mobile-bearing (P.F.C.® Sigma)