Highly Cross-linked Polyethylene in Total Knee Arthroplasty

Highly Cross-linked Polyethylene Versus Compression Mold Conventional Polyethylene in Cruciate-substituting Total Knee Arthroplasty in Young Patients, a Randomized Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03622398

Enrollment

125

Registered

2018-08-09

Start date

2006-01-31

Completion date

2018-06-30

Last updated

2019-07-23

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

Conditions

Knee Arthroplasty, Total

Keywords

total knee arthroplasty, highly cross-linked polyethylene

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.

Interventions

PROCEDURETotal knee arthroplasty with HXLPE liner

Replacing arthritic knee with a metal device, and using a highly cross-linked polyethylene(HXLPE) liner in between metallic surfaces.

PROCEDURETotal knee arthroplasty with conventional polyethylene liner

Replacing arthritic knee with a metal device, and using a conventional polyethylene liner in between metallic surfaces.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Total knee arthroplasty is performed on patients with knee osteoarthritis. One group will receive a highly cross-linked polyethylene liner and one group will receive a conventional polyethylene liner. Other parts of procedures will be the same.

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

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