Highly Cross-linked Polyethylene in Total Knee Arthroplasty

Knee Arthroplasty, Total Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622398
• Other study ID #: XPEPETKA
• Status: Completed
• Phase: Phase 4
• Start date: January 2006
• Est. completion date: June 2018

Study information

• Verified date: July 2019
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 2018
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthroplasty, Total

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee society knee score	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	minimum 10 year follow up after the index surgery
Secondary	WOMAC(Western Ontario and McMaster Universities) Scores	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.	minimum 10 year follow up after the index surgery
Secondary	Range of motion	maximum flexion of the knee	minimum 10 year follow up after the index surgery