Overview

This trial is active, not recruiting.

Condition osteoarthritis of knee
Treatments mobile bearing, fixed bearing
Phase phase 4
Sponsor Seoul National University Hospital
Start date November 2009
End date December 2013
Trial size 80 participants
Trial identifier NCT01027819, SNUHOSK09MBFB

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty
mobile bearing Zimmer LPS-flex mobile bearing type polyethylene insert
Mobile bearing in total knee arthroplasty
(Active Comparator)
Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty
fixed bearing Zimmer LPS-flex fixed bearing in polyethylene insert
Fixed bearing in total knee arthroplasty

Primary Outcomes

Measure
Rotational Angle Between Femur and Tibia
time frame: 2 weeks

Secondary Outcomes

Measure
Knee Society Score
time frame: 6 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - primary total knee arthroplasty Exclusion Criteria: - infection - severe deformity in knee - revision

Additional Information

Official title Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.