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

N/ACompletedNCT02020057

Ewha Womans University319 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

319

Conditions

Osteoarthritis, Knee

Interventions

Total knee arthroplastyPROCEDURE

Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

knee society knee score

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.

Time frame: 3 months, 1 year, and yearly thereafter the operation, until 15 years after the operation

Secondary Outcomes

range of motion

this value will be compared between preoperative and the latest value, and between the latest value of study and control groups

Time frame: preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years

Data from ClinicalTrials.gov

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