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Outcome Study of Highly-cross Linked Polyethylene vs. Standard Polyethylene for Primary Posterior Stabilized (PS) Total Knee

NCT02178020 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2017-02-01

No results posted yet for this study

Summary

Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced to decrease this problem, but there is little data on the results and complications of this polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following questions: (1) Are there any differences in the clinical and radiographic results when a highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency of reoperation in these two groups and are there any specific complications related to highly cross-linked polyethylene liners.

Conditions

  • Arthroplasty, Replacement, Knee

Interventions

DEVICE

knee arthroplasty, standard polyethylene

total knee replacement follow-up; clinical and radiographic; revision rate

DEVICE

knee arthroplasty, XLP polyethylene

total knee arthroplasty with highly crosslinked polyethylene tibial liner

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Chapel Hill Orthopedics Surgery & Sports Medicine

    lead OTHER

Principal Investigators

  • Paul F Lachiewicz, MD · Chapel Hill Orthopedic Surgery and Sports Medicine

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02178020 on ClinicalTrials.gov