Polyethylene Wear Particle Analysis of THA

Recruiting

• Conditions: Hip Arthropathy; Wear of Articular Bearing Surface of Prosthetic Joint
• Interventions: Device: polyethylene

• Registration Number: NCT06432543
• Lead Sponsor: Osaka Metropolitan University

Brief Summary

Purpose of research The purpose of this study was to demonstrate that polyethylene (Vitamin E-containing polyethylene), a newly introduced biomaterial for tibial inserts in hip replacement surgery and widely used clinically, but whose mid- to long-term clinical results are still unknown, is superior to conventional polyethylene in vivo. The aim of this project is to conduct an international multi-center joint research study to determine whether polyethylene wear debris production can be reduced in the future, using an in vivo polyethylene wear debris analysis method that the investigators developed as a method that can provide early feedback.

Detailed Description

Research method In this study, the investigators conducted the following steps to determine the in vivo wear particles (number, size, and morphology) of conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose mid- to long-term results have not yet been clarified. Clarifying the difference.

Target of this research In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment.

First total joint replacement

* 30 patients using polyethylene containing Vitamin E

* 30 patients using conventional polyethylene (no high cross-linking)

* 30 patients using conventional polyethylene (with high cross-linking)

Accumulation of periarticular tissue In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment.

The test will be conducted after obtaining approval from the ethics committee at each facility and obtaining informed consent. The pericapsular tissue, which is removed during surgery and usually discarded, is obtained and fixed in formalin fixative. The tissue will be transported to the Department of Orthopedic Surgery, Osaka Public University Graduate School of Medicine for analysis. International transportation of tissues requires outsourcing to specialized companies with experience in transporting tissues from overseas.

Isolation of polyethylene wear debris The collected tissue around the joint capsule is immersed in 5Mol sodium hydroxide at 65°C for 1 hour to decompose the protein. Make a sucrose layer (5, 10, 20%) in a 14ml tube (14PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the dissolved solution, and place in an ultracentrifuge (CP100a, P28S1014 rotor, Hitachi Koki). Ultracentrifuge at 28,000 rpm \[103,7009g\] for 3 hours at 4°C. Prepare an isopropanol layer (0.90 and 0.96 g/mL) in a 40 ml tube (40PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the upper layer of sucrose layer, and centrifuge at 28,000 rpm (103,7009 g) and perform ultracentrifugation at 4°C for 1 hour. The isopropanol interlayer is collected to isolate polyethylene wear debris.

Analysis of polyethylene wear debris The isopropanol interlayer is filtered through a 0.1 μm polycarbonate filter (VCTP 013-00, Millipore Corporation, Bedford, MA). Dry the polycarbonate filter, fix it on an aluminum pedestal (M4, Nisshin EM Co, Ltd, Tokyo, Japan), and apply platinum coating (E-1030 ion sputter, Hitachi Science Systems Ltd, Tokyo, Japan). Observe the polyethylene wear particles on the polycarbonate filter using a scanning electron microscope (S4700SI, Hitachi Ltd, Tokyo, Japan), and analyze the following items using an image analyzer (Mac Scope, Mitani Co, Tokyo, Japan).

* Number of polyethylene wear particles (number per 1g of tissue)

* Size (Equivalent circle diameter \[μm\])

* Shape (aspect ratio, roundness)

Comparison of iv vivo polyethylene wear powder morphology depending on polyethylene material The number, size, and form of polyethylene wear debris will be compared between conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose medium- to long-term results have not yet been clarified. The investigators also investigated factors that affect polyethylene wear in vivo (age, height, weight, period from initial surgery to revision surgery, hip joint range of motion, hip prosthesis clinical score \[Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement \[HOOS Jr\], Harris Hip Score, University of California Los Angeles \[UCLA\] activity score\]).

Study Timeline

• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-29
• Study Start: 2024-06-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
conventional polyethylene (with highly cross-linking)	polyethylene	conventional polyethylene (with highly cross-linking)
polyethylene containing Vitamin E	polyethylene	polyethylene containing Vitamin E
conventional polyethylene (no highly cross-linking)	polyethylene	conventional polyethylene (no highly cross-linking)

Primary Outcome Measures

Name	Time	Method
Equivalent circle diameter of polyethylene wear particles	When tissue sample was collected during THA revision surgery	equivalent circle diameter \[㎛\]
Aspect ratio of polyethylene wear particles	When tissue sample was collected during THA revision surgery	aspect ratio
Number of polyethylene wear particles	When tissue sample was collected during THA revision surgery	counts / g (tissue sample)
Roundness of polyethylene wear particles	When tissue sample was collected during THA revision surgery	roundness

Secondary Outcome Measures

Name	Time	Method
Hip dysfunction and Osteoarthritis Outcome. Score for Joint Replacement	When tissue sample was collected during THA revision surgery	0(worse)-100(best)
Hip joint adduction angle	When tissue sample was collected during THA revision surgery	Degrees
Body mass index	When tissue sample was collected during THA revision surgery	kg/m2
Hip joint flexion angle	When tissue sample was collected during THA revision surgery	Degrees
Hip joint exertion angle	When tissue sample was collected during THA revision surgery	Degrees
Hip joint abduction angle	When tissue sample was collected during THA revision surgery	Degrees
Harris Hip Score	When tissue sample was collected during THA revision surgery	0(worse)-100(best)
University of California at Los Angeles activity score	When tissue sample was collected during THA revision surgery	１(worse)-10(best)

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Osaka Metropolitan University; 🇯🇵 Osaka, Japan