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

Phase 4

• Conditions: Osteoarthritis of Knee
• Interventions: Device: Mobile bearing; Device: Fixed bearing

• Registration Number: NCT01027819
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-07
• Study First Posted: 2009-12-09
• Results First Submitted: 2011-03-06
• Results First Submitted QC: 2011-03-06
• Results First Posted: 2011-04-05
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-20
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• primary total knee arthroplasty

Exclusion Criteria

• infection
• severe deformity in knee
• revision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile bearing	Mobile bearing	Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty
Fixed bearing	Fixed bearing	Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty

Primary Outcome Measures

Name	Time	Method
Rotational Angle Between Femur and Tibia	2 weeks

Secondary Outcome Measures

Name	Time	Method
Knee Society Score	6 months

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of