Highly Cross-linked Polyethylene in Total Knee Arthroplasty

• Sponsor: Ewha Womans University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03622398
• Collaborator: (none)
• Enrollment: 125
• Arms: 2
• Actual Duration (Months): 149

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Arthroplasty, Total	Procedure: Total knee arthroplasty with HXLPE liner; Procedure: Total knee arthroplasty with conventional polyethylene liner	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Highly Cross-linked Polyethylene Versus Compression Mold Conventional Polyethylene in Cruciate-substituting Total Knee Arthroplasty in Young Patients, a Randomized Trial
• Actual Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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".	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.
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".	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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Range of motion [minimum 10 year follow up after the index surgery]

   maximum flexion of the knee

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ewha Womans University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Young Hoo Kim, Professor, Ewha Womans University
• ClinicalTrials.gov Identifier: NCT03622398
• Other Study ID Numbers: XPEPETKA
• First Posted: Aug 9, 2018
• Last Update Posted: Jul 23, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Young Hoo Kim, Professor, Ewha Womans University: total knee arthroplasty; highly cross-linked polyethylene

Study Results

No Results Posted as of Jul 23, 2019