Highly Cross-linked Polyethylene in Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Knee Arthroplasty, Total
• Interventions: Procedure: Total knee arthroplasty with HXLPE liner; Procedure: Total knee arthroplasty with conventional polyethylene liner

• Registration Number: NCT03622398
• Lead Sponsor: Ewha Womans University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-10
• Study Completion: 2018-06
• Study First Submitted: 2018-07-29
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-21
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HXLPE	Total knee arthroplasty with HXLPE liner	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".
Conventional	Total knee arthroplasty with conventional polyethylene liner	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".

Primary Outcome Measures

Name	Time	Method
Knee society knee score	minimum 10 year follow up after the index surgery	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

Secondary Outcome Measures

Name	Time	Method
WOMAC(Western Ontario and McMaster Universities) Scores	minimum 10 year follow up after the index surgery	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.
Range of motion	minimum 10 year follow up after the index surgery	maximum flexion of the knee