Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432543
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-16
Brief Title:
Polyethylene Wear Particle Analysis of THA
Sponsor:
Osaka Metropolitan University
Organization:
Osaka Metropolitan University
Study Overview
Official Title:
Polyethylene Wear Particle Analysis of Total Hip Arthroplasty -International Multicenter Study-
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 65C 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 28000 rpm 1037009g for 3 hours at 4C Prepare an isopropanol layer 090 and 096 gmL in a 40 ml tube 40PA tube Hitachi Koki Co Ltd Tokyo Japan add the upper layer of sucrose layer and centrifuge at 28000 rpm 1037009 g and perform ultracentrifugation at 4C 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 01 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
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 65C 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 28000 rpm 1037009g for 3 hours at 4C Prepare an isopropanol layer 090 and 096 gmL in a 40 ml tube 40PA tube Hitachi Koki Co Ltd Tokyo Japan add the upper layer of sucrose layer and centrifuge at 28000 rpm 1037009 g and perform ultracentrifugation at 4C 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 01 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None