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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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