NCT01075620

Brief Summary

The purpose of this study is to determine if there are any clinical or radiographic differences in non-posterior stabilized rotating mobile bearing design versus a posterior stabilized rotating mobile bearing designs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
Last Updated

February 25, 2010

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

February 16, 2010

Last Update Submit

February 24, 2010

Conditions

Osteoarthritis

Keywords

rotating platformposterior stabilizednon-posterior stabilized

Outcome Measures

Primary Outcomes (1)

  • Knee Society knee score

    at 3 months, 1 year, than annually

Secondary Outcomes (1)

  • Range of motion

    at 3 months, 1 year, than annually

Study Arms (2)

PFC sigma RP

EXPERIMENTAL

Posterior stabilized rotating platform knee (press Fit Condylar Sigma rotating-platform, Depuy, Warsaw, Indiana)

Device: PFC-Sigma RP

LCS RP

ACTIVE COMPARATOR

non posterior stabilized Low Contact Stress Rotating-Platform; Depuy, Warsaw, Indiana

Device: LPS RP

Interventions

PFC-Sigma RPDEVICE

Posterior stabilizing rotating platform total knee components

Also known as: PFC sigma RP
PFC sigma RP
LPS RPDEVICE

non-posterior stabilized rotating platform design

Also known as: LCS RP
LCS RP

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

You may not qualify if:

  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Yoowang Choi, MD

    Ewha Womans University Mokdong Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 25, 2010

Study Start

May 1, 2002

Primary Completion

December 1, 2002

Study Completion

January 1, 2010

Last Updated

February 25, 2010

Record last verified: 2010-01

Locations

KR(1)