NCT01027819

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 5, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

4.1 years

First QC Date

December 7, 2009

Results QC Date

March 6, 2011

Last Update Submit

December 13, 2012

Conditions

Osteoarthritis of Knee

Keywords

Total knee arthroplastyMobile bearingFixed bearingRange of motionKnee Society Score

Outcome Measures

Primary Outcomes (1)

  • Rotational Angle Between Femur and Tibia

    2 weeks

Secondary Outcomes (1)

  • Knee Society Score

    6 months

Study Arms (2)

Mobile bearing

ACTIVE COMPARATOR

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

Device: Mobile bearing

Fixed bearing

ACTIVE COMPARATOR

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

Device: Fixed bearing

Interventions

Mobile bearingDEVICE

Mobile bearing in total knee arthroplasty

Also known as: Zimmer LPS-flex mobile bearing type polyethylene insert
Mobile bearing
Fixed bearingDEVICE

Fixed bearing in total knee arthroplasty

Also known as: Zimmer LPS-flex fixed bearing in polyethylene insert
Fixed bearing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary total knee arthroplasty

You may not qualify if:

  • infection
  • severe deformity in knee
  • revision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

First, our study population is composed of elderly patients with large female dominance Second concern was inherent errors in making the measurements in this kind of study

Results Point of Contact

Title
Dr. Dongwook Kim
Organization
Seoul National University Hospital
daljookim@gmail.com
821067395311

Study Officials

  • Myung Chul Lee, M.D., Ph. D.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2013

Last Updated

December 20, 2012

Results First Posted

April 5, 2011

Record last verified: 2012-12

Locations

KR(1)