Highly Cross-linked Polyethylene in Total Knee Arthroplasty

Study Overview
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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.

Official Title
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Highly Cross-linked Polyethylene Versus Compression Mold Conventional Polyethylene in Cruciate-substituting Total Knee Arthroplasty in Young Patients, a Randomized Trial

Conditions
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Knee Arthroplasty, Total

Intervention / Treatment
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* Procedure: Total knee arthroplasty with HXLPE liner
* Procedure: Total knee arthroplasty with conventional polyethylene liner


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HXLPE<br>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. | Procedure: Total knee arthroplasty with HXLPE liner<br>* Replacing arthritic knee with a metal device, and using a highly cross-linked polyethylene(HXLPE) liner in between metallic surfaces.<br>|
| Active Comparator: Conventional<br>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. | Procedure: Total knee arthroplasty with conventional polyethylene liner<br>* Replacing arthritic knee with a metal device, and using a conventional polyethylene liner in between metallic surfaces.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee society knee score | a proven score for the measurement of knee function, the score ranges from 0 to 100, 100 being the best possible score, indicating normal knee function | minimum 10 year follow up after the index surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC(Western Ontario and McMaster Universities) Scores | A tool to evaluate patient function associated with knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The total score is summed from individual sections, and 0 is the best possible score. | minimum 10 year follow up after the index surgery | 
| Range of motion | maximum flexion of the knee | minimum 10 year follow up after the index surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, highly cross-linked polyethylene