NCT00954954

Brief Summary

The aim of this prospective study is to compare the clinical and radiographic outcomes of standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB) total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed with a high-flexion PS RP-MB design would improve range of motion, and that this would be reflected by a better clinical outcome and greater patient satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2006

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

8 months

First QC Date

August 5, 2009

Last Update Submit

August 6, 2009

Conditions

Osteoarthritis, Knee

Keywords

ArthroplastyReplacementKneeRange of Motion

Outcome Measures

Primary Outcomes (1)

  • Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured.

    2 years

Study Arms (2)

Standard

ACTIVE COMPARATOR

Knees that will be implanted with standard posterior stabilized RP-MB knee prostheses

Device: Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)

High-flexion

ACTIVE COMPARATOR

Knees that will be implanted with high-flexion posterior stabilized RP-MB knee prostheses

Device: High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)

Interventions

Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)DEVICE

Comparison of different types of knee prosthesis

Also known as: P.F.C Sigma Rotating Platform knee
Standard
High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)DEVICE

Comparison of different types of knee prosthesis

Also known as: P.F.C Sigma Rotating Platform Flex
High-flexion

Eligibility Criteria

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

You may qualify if:

  • A diagnosis of primary osteoarthritis of knee
  • A candidate for total knee replacement arthroplasty

You may not qualify if:

  • A diagnosis other than primary osteoarthritis
  • A history of previous open knee surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital Department of Orthopaedic Surgery

Seoul, 28, Yongeon-Dong, Jongno-Gu, 110-744, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Myung Chul Lee, MD, PhD

    Seoul National University Hospital Department of Orthopaedic Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

October 1, 2006

Primary Completion

June 1, 2007

Study Completion

July 1, 2009

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

KR(1)