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

Ewha Womans University

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Procedure: Total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02020057

2006-32

PSXL

Details and patient eligibility

About

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.

Enrollment: 319 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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319 participants in 2 patient groups

Conventional

Active Comparator group

Description:

knee receiving Total knee arthroplasty with conventional polyethylene inserts

Treatment:

Procedure: Total knee arthroplasty

Prolong

Experimental group

Description:

knee receiving total knee arthroplasty with highly cross linked polyethylene insert

Treatment:

Procedure: Total knee arthroplasty