Highly Cross-linked Polyethylene in Total Knee Arthroplasty

NCT03622398 | Completed Phase 4 DMC

• 1 other identifier: XPEPETKA
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Arthroplasty, Total

Keywords

total knee arthroplasty; highly cross-linked polyethylene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• WOMAC(Western Ontario and McMaster Universities) Scores

  minimum 10 year follow up after the index surgery

• Range of motion

  minimum 10 year follow up after the index surgery

Study Arms (2)

HXLPE

EXPERIMENTAL

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

Conventional

ACTIVE COMPARATOR

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

Interventions

Total knee arthroplasty with HXLPE liner PROCEDURE

Replacing arthritic knee with a metal device, and using a highly cross-linked polyethylene(HXLPE) liner in between metallic surfaces.

HXLPE

Total knee arthroplasty with conventional polyethylene liner PROCEDURE

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

Conventional

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Younger than 65 years old
• with end stage knee arthritis bad enough for knee replacement

You may not qualify if:

• inflammatory arthritis
• combined foot and ankle disorders.
• dementia
• patient older than 65 years old.

Sponsors & Collaborators

• Ewha Womans University: lead

Related Publications (5)

• 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.

  PMID: 7706337 BACKGROUND

• 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.

  PMID: 11263644 BACKGROUND

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

  PMID: 11451106 BACKGROUND

• 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.

  PMID: 18781371 BACKGROUND

• 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.

  PMID: 23102419 BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 9, 2018
• Study Start: January 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: June 1, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share