Highly Cross-linked Polyethylene in Total Knee Arthroplasty

Overview

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.

Full Title of Study: “Highly Cross-linked Polyethylene Versus Compression Mold Conventional Polyethylene in Cruciate-substituting Total Knee Arthroplasty in Young Patients, a Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 2008

Interventions

  • Procedure: Total 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.
  • Procedure: Total knee arthroplasty with conventional polyethylene liner
    • Replacing arthritic knee with a metal device, and using a conventional polyethylene liner in between metallic surfaces.

Arms, Groups and Cohorts

  • Experimental: HXLPE
    • This side of knee implanted with HXLPE(highly crosslinked polyethylene) liner while undergoing total knee arthroplasty. This group will receive the intervention, “Total knee arthroplasty with HXLPE liner”.
  • Active Comparator: Conventional
    • This side of knee implanted with conventional polyethylene while undergoing standard total knee arthroplasty. This group will receive the intervention, “Total knee arthroplasty with conventional polyethylene liner”.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • Range of motion
    • Time Frame: minimum 10 year follow up after the index surgery
    • maximum flexion of the knee

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ewha Womans University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Young Hoo Kim, Professor – Ewha Womans University

References

Kim YH, Oh JH, Oh SH. Osteolysis around cementless porous-coated anatomic knee prostheses. J Bone Joint Surg Br. 1995 Mar;77(2):236-41.

Mikulak SA, Mahoney OM, dela Rosa MA, Schmalzried TP. Loosening and osteolysis with the press-fit condylar posterior-cruciate-substituting total knee replacement. J Bone Joint Surg Am. 2001 Mar;83(3):398-403. doi: 10.2106/00004623-200103000-00012.

Rodriguez JA, Bhende H, Ranawat CS. Total condylar knee replacement: a 20-year followup study. Clin Orthop Relat Res. 2001 Jul;(388):10-7.

Hodrick JT, Severson EP, McAlister DS, Dahl B, Hofmann AA. Highly crosslinked polyethylene is safe for use in total knee arthroplasty. Clin Orthop Relat Res. 2008 Nov;466(11):2806-12. doi: 10.1007/s11999-008-0472-4. Epub 2008 Sep 10.

Long WJ, Levi GS, Scuderi GR. Highly cross-linked polyethylene in posterior stabilized total knee arthroplasty: early results. Orthop Clin North Am. 2012 Nov;43(5):e35-8. doi: 10.1016/j.ocl.2012.07.005. Epub 2012 Sep 27.

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