NCT01361152

Brief Summary

The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare

  1. 1.functional scores
  2. 2.rates of radiographic failure
  3. 3.revision rates
  4. 4.survivorship

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 1993

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

April 1, 1993

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1996

Completed
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

2.9 years

First QC Date

May 17, 2011

Last Update Submit

October 4, 2011

Conditions

Osteoarthritis

Keywords

total knee arthroplastyfixed-bearingmobile-bearinglong-term

Outcome Measures

Primary Outcomes (1)

  • Improvement in Knee Society Knee Score

    change in knee score will be compared with initial score, until follow up of 18 years

    18 years

Secondary Outcomes (1)

  • Improvement in the range of motion

    18 years

Study Arms (2)

Fixed-bearing group

EXPERIMENTAL

Fixed-bearing group

Device: anatomic modular fixed-bearing

Mobile-bearing group

EXPERIMENTAL

Mobile-bearing group

Device: low contact stress rotating platform mobile-bearing

Interventions

anatomic modular fixed-bearingDEVICE

anatomic modular (AMK; DePuy) fixed-bearing prosthesis

Also known as: AMK
Fixed-bearing group
low contact stress rotating platform mobile-bearingDEVICE

low contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis

Also known as: LCS RP
Mobile-bearing group

Eligibility Criteria

Age29 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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 Hosptial

Seoul, 158-710, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Young-Hoo Kim, MD

    Ewha Womans University Mokdong Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 26, 2011

Study Start

April 1, 1993

Primary Completion

March 1, 1996

Study Completion

March 1, 2011

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations

KR(1)