Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis of Knee

Treatments: Device: Mobile bearing; Device: Fixed bearing

Study type: Interventional

Funder types: Other

Identifiers

NCT01027819

SNUHOSK09MBFB (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the clinical and radiological outcomes of mobile-bearing with that of fixed-bearing in total knee arthroplasty.

Full description

Double blind, randomized prospective study Mobile or fixed bearing of the same company

• Mobile bearing group : group M
• Fixed bearing group : group F

Inclusion criteria

• patients expected primary total knee arthroplasty without severe deformity

Clinical outcomes

• Range of motion

• Complication

• Scorings

  • KSS, KSFS, HSS score, WOMAC score, Oxford score, SF-36

Radiological outcomes

• Alignment angles in knee
• Positions of femoral and tibial components
• Position of patella
• Radiolucency

Enrollment: 80 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary total knee arthroplasty

Exclusion criteria

• infection
• severe deformity in knee
• revision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Mobile bearing

Active Comparator group

Description:

Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty

Treatment:

Device: Mobile bearing

Fixed bearing

Active Comparator group

Description:

Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty

Treatment:

Device: Fixed bearing