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Completed

NCT Number: NCT02020057

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Total knee arthroplasty

Procedure

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

Primary outcomes

  1. knee society knee score

    Time frame: 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 outcomes

  1. range of motion

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2013
First posted
Dec 24, 2013
Registry last updated
Dec 24, 2013

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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