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

Comparison of Highly Cross-Linked and Conventional Polyethylene in Posterior Cruciate-Substituting Total Knee Arthroplasty in the Same Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02020057

Enrollment

319

Registered

2013-12-24

Start date

2006-02-28

Completion date

2013-09-30

Last updated

2013-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

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.

Interventions

PROCEDURETotal knee arthroplasty

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026