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

NCT ID: NCT01361152

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-04-30

Study Completion Date

2011-03-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Fixed-bearing group

Fixed-bearing group

Group Type EXPERIMENTAL

anatomic modular fixed-bearing

Intervention Type DEVICE

anatomic modular (AMK; DePuy) fixed-bearing prosthesis

Mobile-bearing group

Mobile-bearing group

Group Type EXPERIMENTAL

low contact stress rotating platform mobile-bearing

Intervention Type DEVICE

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

Interventions

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anatomic modular fixed-bearing

anatomic modular (AMK; DePuy) fixed-bearing prosthesis

Intervention Type DEVICE

low contact stress rotating platform mobile-bearing

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

Intervention Type DEVICE

Other Intervention Names

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AMK LCS RP

Eligibility Criteria

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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
Minimum Eligible Age

29 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Young Hoo Kim

Professor and Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Hoo Kim, MD

Role: STUDY_DIRECTOR

Ewha Womans University Mokdong Hospital

Locations

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Ewha Womans University Mokdong Hosptial

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Fixed- and Mobile TKA

Identifier Type: -

Identifier Source: org_study_id