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Completed

NCT Number: NCT03622398

Highly Cross-linked Polyethylene in Total Knee Arthroplasty

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.

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Key information

Conditions

Knee Arthroplasty, Total

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total knee arthroplasty with HXLPE liner

Procedure

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

Total knee arthroplasty with conventional polyethylene liner

Procedure

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

Primary outcomes

  1. Knee society knee score

    Time frame: 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 outcomes

  1. WOMAC(Western Ontario and McMaster Universities) Scores

    Time frame: 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.

  2. Range of motion

    Time frame: minimum 10 year follow up after the index surgery

    maximum flexion of the knee

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2018
First posted
Aug 9, 2018
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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