Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175162
Status:
WITHDRAWN
Last Update Posted:
2022-12-19
First Post:
2005-09-10
Brief Title:
A Comparison of Fixation Method in Total Knee Arthroplasty - Low Viscosity Versus High Viscosity Bone Cement
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
A Comparison of Fixation Method in Total Knee Arthroplasty - Low Viscosity Versus High Viscosity Bone Cement A Prospective Randomized Migration- and Bone Density Study on Primary Cemented Knee Implants
Status:
WITHDRAWN
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No financing possible
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 is to compare the early migration and periprosthetic bone changes of two total knee arthroplasties fixated with two different type bone cement
Detailed Description:
Around 4 of total knee arthroplasties TKA are revised 15 years after the primary operation most due to loosening of the implant About 70 TKA are fixed with bone cement and in general the results after total knee arthroplasty are excellent and with the existing technique about 95 well functioning prostheses can be expected 10 years post surgery The most serious late complication to surgery is aseptic loosening of the implants and this remains one of the main courses of failure of both uncemented and cemented total knee implants
Implant design method of fixation the quality of bone cement surgerytechnique and the bone mass density are some of the factors that have a large influence on implant stability Fixation of the tibia baseplates in total knee arthroplasty can be obtained by different type bone cement
In this project we are using a modular tibia component with a central wedge-shaped stem Upon randomization at surgery the implant is consolidated in the bone with either low-viscosity or high-viscosity bone cement
The purpose of this study is to compare the early migration of a total knee implant fixated with two different bone cements using RSA radio stereophotogrammetric analysis for evaluation Furthermore we will make research into the periprosthetic bone and its changes post surgery using DEXA Finally the extend of the expected micromovements between the polyethylen liner and the metal backing of the titanium plateau will be compared and taken into account with the results
Several factors can influence the long-term survival of cemented TKA Bone-sclerosing at the tibia condyles may induce a problem with cement penetration into the cancellous bone Furthermore blood-contamination in the cancellous bone may reduce the shear-strength at the bone-cement site by 50 A solid cement-implant interface limits the amount of debris in the interface bringing down the risk of radiolucent lines and osteolysis The tibial implant used in this study is designed with a rim under the plateau to support the cement layer on the tibial condyles at the time of fixation The implant has a stem making it more resistant to shearing forces In this study we primarily consider the bone cement viscosity on the outcome Both types are used in hip-arthroplasties with good results
To evaluate both the implant-bone micromotions and the polyethylen-implant micromovements metal markers have been placed on the tibial implants pre-operatively They will also be inserted into the tibial bone and into the tibial polyethylen intra-operatively allowing us to evaluate stereo x-rays by a photogrammetric computer analyses called RSA at the Orthopaedic Center Aarhus University Hospital Follow-up stereo x-rays will be scheduled for 1 week 3 months 6 month 1 years and 2 years post-surgery Periprostetic bone density will be evaluated at 1 week 1 year and 2 years upon inclusion at the Orthopaedic Center Aarhus University Hospital
Implant design method of fixation the quality of bone cement surgerytechnique and the bone mass density are some of the factors that have a large influence on implant stability Fixation of the tibia baseplates in total knee arthroplasty can be obtained by different type bone cement
In this project we are using a modular tibia component with a central wedge-shaped stem Upon randomization at surgery the implant is consolidated in the bone with either low-viscosity or high-viscosity bone cement
The purpose of this study is to compare the early migration of a total knee implant fixated with two different bone cements using RSA radio stereophotogrammetric analysis for evaluation Furthermore we will make research into the periprosthetic bone and its changes post surgery using DEXA Finally the extend of the expected micromovements between the polyethylen liner and the metal backing of the titanium plateau will be compared and taken into account with the results
Several factors can influence the long-term survival of cemented TKA Bone-sclerosing at the tibia condyles may induce a problem with cement penetration into the cancellous bone Furthermore blood-contamination in the cancellous bone may reduce the shear-strength at the bone-cement site by 50 A solid cement-implant interface limits the amount of debris in the interface bringing down the risk of radiolucent lines and osteolysis The tibial implant used in this study is designed with a rim under the plateau to support the cement layer on the tibial condyles at the time of fixation The implant has a stem making it more resistant to shearing forces In this study we primarily consider the bone cement viscosity on the outcome Both types are used in hip-arthroplasties with good results
To evaluate both the implant-bone micromotions and the polyethylen-implant micromovements metal markers have been placed on the tibial implants pre-operatively They will also be inserted into the tibial bone and into the tibial polyethylen intra-operatively allowing us to evaluate stereo x-rays by a photogrammetric computer analyses called RSA at the Orthopaedic Center Aarhus University Hospital Follow-up stereo x-rays will be scheduled for 1 week 3 months 6 month 1 years and 2 years post-surgery Periprostetic bone density will be evaluated at 1 week 1 year and 2 years upon inclusion at the Orthopaedic Center Aarhus University Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None