Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties (TKAs) in Patients With OA ≤50 Years Old

October 4, 2011 updated by: Young Hoo Kim, Ewha Womans University

Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties in Patients With Osteoarthritis Younger Than Fifty Years of Age

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The randomized prospective comparison of fixed- and mobile-bearing total knee designs in the same patients younger than fifty years of age is limited. The purpose of this study was to compare the long-term clinical and radiographic results of fixed- and mobile-bearing total knee arthroplasties in patients younger than fifty years of age with osteoarthritis.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 158-710
        • Ewha Womans University Mokdong Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

29 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fixed-bearing group
Device: anatomic modular fixed-bearing
anatomic modular (AMK; DePuy) fixed-bearing prosthesis
Other Names:
  • AMK
Experimental: Mobile-bearing group
Device: low contact stress rotating platform mobile-bearing
low contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis
Other Names:
  • LCS RP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Knee Society Knee Score
Time Frame: 18 years
change in knee score will be compared with initial score, until follow up of 18 years
18 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the range of motion
Time Frame: 18 years
change in the range of motion of knee joint will be compared with the initial value, until follow up of 18 years.
18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University

Investigators

  • Study Director: Young-Hoo Kim, MD, Ewha Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1993

Primary Completion (Actual)

March 1, 1996

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 25, 2011

First Posted (Estimate)

May 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 5, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fixed- and Mobile TKA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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