Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426641
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-16
Brief Title:
Polyethylene Wear Particle Analysis of TKA
Sponsor:
Osaka Metropolitan University
Organization:
Osaka Metropolitan University
Study Overview
Official Title:
Polyethylene Wear Particle Analysis of Total Knee Arthroplasty -International Multicenter Study-
Status:
ACTIVE_NOT_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:
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
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
Detailed Description:
Anticipated medical contribution and significance In this study the investigators investigate whether a newly introduced polyethylene highly cross-linked polyethylene vitamin E-containing polyethylene in vivo can suppress wear debris production more than conventional polyethylene If the newly introduced polyethylene can reduce wear debris production it is expected to reduce failure of artificial joints in the future However if newly introduced polyethylene is actually increasing wear debris production it could be an early alarm bell for surgeons around the world In other words the international and social impact of this research is extremely large
Two unique requirements are necessary to carry out this research Firstly in vivo analysis of polyethylene wear particles is possible and secondly the number of surgical cases of revision knee arthroplasty targeted for investigation is large The first requirement is that the applicants have published many English-language papers on in vivo polyethylene wear debris analysis and that their facilities are the most suitable and fully capable of carrying out the analysis worldwide be The second requirement is that the investigators need to collaborate not only with our hospital but also with facilities that perform a large number of revision knee arthroplasty surgeries Not only our hospital but also our affiliated hospital which is one of the facilities in Japan that performs the most knee joint surgeries Naniwa Ikuno Hospital and the hospital that performs the most knee joint surgeries worldwide Mayo Clinic USA Hospital for Special Surgery USA Istituto Ortopedico Rizzoli Italy
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 Figure 3
Target of this research In this study the investigators will focus on patients undergoing revision knee arthroplasty as a routine medical treatment
First total joint replacement
30 patients using polyethylene containing Vitamin E
30 patients using conventional polyethylene no highly cross-linking
30 patients using conventional polyethylene with highly cross-linking
Accumulation of periarticular tissue In this study the investigators will focus on patients undergoing revision knee 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 5M NaOH 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 knee joint range of motion knee prosthesis clinical score Knee Society Score University of California at Los Angeles activity score
Evaluation items outcome Main evaluation items Polyethylene wear particle morphology number of wear particles equivalent circle diameter aspect ratio roundness Reason for setting primary endpoints Because it is a standard evaluation item for evaluating polyethylene wear debris
Secondary endpoints
Body mass index
Knee joint range of motion
Clinical score 2011Knee Society Score Knee injury and Osteoarthritis Outcome Score for Joint Replacement University of California at Los Angeles activity score Reason for setting secondary endpoints Because it may affect the production of polyethylene wear debris
Planned number of research subjects and basis for setting it including cases where the number of research subjects is set without relying on statistical grounds Total 90 cases
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 Rationale for setting The target number of cases was determined from the number of cases at related institutions within the study period
Two unique requirements are necessary to carry out this research Firstly in vivo analysis of polyethylene wear particles is possible and secondly the number of surgical cases of revision knee arthroplasty targeted for investigation is large The first requirement is that the applicants have published many English-language papers on in vivo polyethylene wear debris analysis and that their facilities are the most suitable and fully capable of carrying out the analysis worldwide be The second requirement is that the investigators need to collaborate not only with our hospital but also with facilities that perform a large number of revision knee arthroplasty surgeries Not only our hospital but also our affiliated hospital which is one of the facilities in Japan that performs the most knee joint surgeries Naniwa Ikuno Hospital and the hospital that performs the most knee joint surgeries worldwide Mayo Clinic USA Hospital for Special Surgery USA Istituto Ortopedico Rizzoli Italy
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 Figure 3
Target of this research In this study the investigators will focus on patients undergoing revision knee arthroplasty as a routine medical treatment
First total joint replacement
30 patients using polyethylene containing Vitamin E
30 patients using conventional polyethylene no highly cross-linking
30 patients using conventional polyethylene with highly cross-linking
Accumulation of periarticular tissue In this study the investigators will focus on patients undergoing revision knee 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 5M NaOH 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 knee joint range of motion knee prosthesis clinical score Knee Society Score University of California at Los Angeles activity score
Evaluation items outcome Main evaluation items Polyethylene wear particle morphology number of wear particles equivalent circle diameter aspect ratio roundness Reason for setting primary endpoints Because it is a standard evaluation item for evaluating polyethylene wear debris
Secondary endpoints
Body mass index
Knee joint range of motion
Clinical score 2011Knee Society Score Knee injury and Osteoarthritis Outcome Score for Joint Replacement University of California at Los Angeles activity score Reason for setting secondary endpoints Because it may affect the production of polyethylene wear debris
Planned number of research subjects and basis for setting it including cases where the number of research subjects is set without relying on statistical grounds Total 90 cases
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 Rationale for setting The target number of cases was determined from the number of cases at related institutions within the study period
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