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Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty

NCT ID: NCT02020057

Last Updated: 2013-12-24

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

NA

Total Enrollment

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2013-09-30

Brief Summary

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To our knowledge, there has been no information on in vivo clinical results of posterior cruciate-substituting arthroplasties using highly cross-linked polyethylene. We evaluated whether the clinical and radiographic results, incidence of post fracture of the tibial polyethylene insert, failure of the locking mechanism of the tibial polyethylene insert, and the incidence of osteolysis would be similar between posterior cruciate-substituting total knee prostheses using conventional and highly cross-linked polyethylene.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional

knee receiving Total knee arthroplasty with conventional polyethylene inserts

Group Type ACTIVE_COMPARATOR

Total knee arthroplasty

Intervention Type PROCEDURE

Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.

Prolong

knee receiving total knee arthroplasty with highly cross linked polyethylene insert

Group Type EXPERIMENTAL

Total knee arthroplasty

Intervention Type PROCEDURE

Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.

Interventions

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Total knee arthroplasty

Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties

Exclusion Criteria

* inflammatory arthritis
* osteoarthritis of the hip causing pain or restricted mobility
* a foot or ankle disorder which limited walking
* dementia or a neurological disorder including a past history of stroke which affected mobility
Minimum Eligible Age

20 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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Hoo Kim, M.D.

Role: STUDY_DIRECTOR

Ewha Womans University Mokdong Hospital

Other Identifiers

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2006-32

Identifier Type: OTHER

Identifier Source: secondary_id

PSXL

Identifier Type: -

Identifier Source: org_study_id