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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Total knee arthroplasty

• Registration Number: NCT02020057
• Lead Sponsor: Ewha Womans University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2010-08
• Study Completion: 2013-09
• Status Verified: 2013-12
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2013-12-18
• Last Update Submitted: 2013-12-18
• Study First Posted: 2013-12-24
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Total knee arthroplasty	knee receiving Total knee arthroplasty with conventional polyethylene inserts
Prolong	Total knee arthroplasty	knee receiving total knee arthroplasty with highly cross linked polyethylene insert

Primary Outcome Measures

Name	Time	Method
knee society knee score	3 months, 1 year, and yearly thereafter the operation, until 15 years after the operation	clinical evaluation of knee function by knee score. This knee score will be compared, between preoperative and the latest score, and between the latest scores of study and control group.

Secondary Outcome Measures

Name	Time	Method
range of motion	preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years	this value will be compared between preoperative and the latest value, and between the latest value of study and control groups