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

Phase 4

• Conditions: Osteoarthritis of Knee

• 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

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