Polyethylene Wear Particle Analysis of TKA

NCT06426641 | Active Not Recruiting FDA Device

• 1 other identifier: OMU 2023-108
• Study Type: observational
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study was to investigate whether polyethylene (Vitamin E-containing polyethylene), which has been newly introduced and widely used clinically as a biomaterial for tibial inserts in total knee arthroplasty, but whose mid- to long-term clinical results are still unknown, is more effective than conventional polyethylene. Our goal is to clarify through an international multi-center joint study using in vivo polyethylene wear particle analysis, which the investigators developed as a method to provide early feedback, as to whether polyethylene wear debris production in vivo can be reduced.

Conditions

Wear of Articular Bearing Surface of Prosthetic Joint; Total Knee Arthroplasty

Keywords

Polyethylene wear particle

Outcome Measures

Primary Outcomes (4)

• Number of polyethylene wear particles

  counts / g (tissue sample)

  Time of revision surgery

• Equivalent circle diameter of polyethylene wear particles

  Equivalent circle diameter (㎛)

  Time of revision surgery

• Aspect ratio of polyethylene wear particles

  Aspect ratio

  Time of revision surgery

• Roundness of polyethylene wear particles

  Roundness

  Time of revision surgery

Secondary Outcomes (9)

• Body mass index

  Time of revision surgery

• Knee joint extension angle

  Time of revision surgery

• Knee joint flexion angle

  Time of revision surgery

• 2011 Knee Society Score: An "Objective" Knee Score

  Time of revision surgery

• 2011 Knee Society Score: A Patient Satisfaction Score

  Time of revision surgery

Study Arms (3)

polyethylene containing Vitamin E

polyethylene containing Vitamin E

Device: Polyethylene

conventional polyethylene (no highly cross-linking)

conventional polyethylene (no highly cross-linking)

Device: Polyethylene

conventional polyethylene (with highly cross-linking)

conventional polyethylene (with highly cross-linking)

Device: Polyethylene

Interventions

Polyethylene DEVICE

There is no intervention

conventional polyethylene (no highly cross-linking); conventional polyethylene (with highly cross-linking); polyethylene containing Vitamin E

Eligibility Criteria

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

Study Population

Patients undergoing revision surgery

You may qualify if:

• Patients undergoing revision knee arthroplasty within the study period
• Patients over 20 years old
• Patients who have received a sufficient explanation, have sufficient understanding, and have given their free written consent.
• Patients who have passed 2 years or more since their first total knee arthroplasty

You may not qualify if:

• \. Patients who are judged to be unsuitable as research subjects by the research physician

Sponsors & Collaborators

• Osaka Metropolitan University: lead
• Mayo Clinic: collaborator
• Istituto Ortopedico Rizzoli: collaborator
• Hospital for Special Surgery, New York: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Osaka Metroplitan Univerity

Osaka, 545-8585, Japan

Location

Related Publications (2)

• Minoda Y, Kobayashi A, Iwaki H, Iwakiri K, Inori F, Sugama R, Ikebuchi M, Kadoya Y, Takaoka K. In vivo analysis of polyethylene wear particles after total knee arthroplasty: the influence of improved materials and designs. J Bone Joint Surg Am. 2009 Nov;91 Suppl 6:67-73. doi: 10.2106/JBJS.I.00447. No abstract available.

  PMID: 19884413 RESULT

• Minoda Y, Kobayashi A, Iwaki H, Miyaguchi M, Kadoya Y, Ohashi H, Yamano Y, Takaoka K. Polyethylene wear particles in synovial fluid after total knee arthroplasty. Clin Orthop Relat Res. 2003 May;(410):165-72. doi: 10.1097/01.blo.0000063122.39522.c2.

  PMID: 12771827 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

pericapsular tissue, which is removed during surgery

Study Officials

• Yukihide Minoda, MD, PhD

  Osaka Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 23, 2024
• Study Start: December 5, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); JP (1)