Highly Cross-linked Polyethylene in Total Knee Arthroplasty

NCT ID: NCT03622398

Last Updated: 2019-07-23

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

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2018-06-30

Brief Summary

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The aim of this study was to determine clinical and radiographic results after posterior cruciate-substituting total knee arthroplasties with highly cross-linked polyethylene in one knee and compression mold conventional polyethylene in the contralateral knee in the same patients.

Detailed Description

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Conditions

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Knee Arthroplasty, Total

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Total knee arthroplasty is performed on patients with knee osteoarthritis. One group will receive a highly cross-linked polyethylene liner and one group will receive a conventional polyethylene liner. Other parts of procedures will be the same.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HXLPE

This side of knee implanted with HXLPE(highly crosslinked polyethylene) liner while undergoing total knee arthroplasty. This group will receive the intervention, "Total knee arthroplasty with HXLPE liner".

Group Type EXPERIMENTAL

Total knee arthroplasty with HXLPE liner

Intervention Type PROCEDURE

Replacing arthritic knee with a metal device, and using a highly cross-linked polyethylene(HXLPE) liner in between metallic surfaces.

Conventional

This side of knee implanted with conventional polyethylene while undergoing standard total knee arthroplasty. This group will receive the intervention, "Total knee arthroplasty with conventional polyethylene liner".

Group Type ACTIVE_COMPARATOR

Total knee arthroplasty with conventional polyethylene liner

Intervention Type PROCEDURE

Replacing arthritic knee with a metal device, and using a conventional polyethylene liner in between metallic surfaces.

Interventions

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Total knee arthroplasty with HXLPE liner

Replacing arthritic knee with a metal device, and using a highly cross-linked polyethylene(HXLPE) liner in between metallic surfaces.

Intervention Type PROCEDURE

Total knee arthroplasty with conventional polyethylene liner

Replacing arthritic knee with a metal device, and using a conventional polyethylene liner in between metallic surfaces.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Younger than 65 years old
* with end stage knee arthritis bad enough for knee replacement

Exclusion Criteria

* inflammatory arthritis
* combined foot and ankle disorders.
* dementia
* patient older than 65 years old.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 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

References

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Kim YH, Oh JH, Oh SH. Osteolysis around cementless porous-coated anatomic knee prostheses. J Bone Joint Surg Br. 1995 Mar;77(2):236-41.

Reference Type BACKGROUND
PMID: 7706337 (View on PubMed)

Mikulak SA, Mahoney OM, dela Rosa MA, Schmalzried TP. Loosening and osteolysis with the press-fit condylar posterior-cruciate-substituting total knee replacement. J Bone Joint Surg Am. 2001 Mar;83(3):398-403. doi: 10.2106/00004623-200103000-00012.

Reference Type BACKGROUND
PMID: 11263644 (View on PubMed)

Rodriguez JA, Bhende H, Ranawat CS. Total condylar knee replacement: a 20-year followup study. Clin Orthop Relat Res. 2001 Jul;(388):10-7.

Reference Type BACKGROUND
PMID: 11451106 (View on PubMed)

Hodrick JT, Severson EP, McAlister DS, Dahl B, Hofmann AA. Highly crosslinked polyethylene is safe for use in total knee arthroplasty. Clin Orthop Relat Res. 2008 Nov;466(11):2806-12. doi: 10.1007/s11999-008-0472-4. Epub 2008 Sep 10.

Reference Type BACKGROUND
PMID: 18781371 (View on PubMed)

Long WJ, Levi GS, Scuderi GR. Highly cross-linked polyethylene in posterior stabilized total knee arthroplasty: early results. Orthop Clin North Am. 2012 Nov;43(5):e35-8. doi: 10.1016/j.ocl.2012.07.005. Epub 2012 Sep 27.

Reference Type BACKGROUND
PMID: 23102419 (View on PubMed)

Other Identifiers

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XPEPETKA

Identifier Type: -

Identifier Source: org_study_id

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