Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00138853
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2005-08-29
Brief Title:
A Roentgen Stereophotogrammetric Analysis on Migration of Knee Prostheses
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
A Roentgen Stereophotogrammetric Analysis on Migration of Knee Prostheses A Randomised Prospective Study of Tantalum Versus Titanium Implants
Status:
COMPLETED
Status Verified Date:
2020-02
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:
Ti-Tan
Brief Summary:
The purpose of this study is to compare the early migration of two uncemented total knee arthroplasties with different metal coating Only the tibial prosthesis plateau varies One is made out of tantalum and has two short pegs for fixation into the tibia while the other is covered by titanium fiber-mesh on the bone-near site and has 4 short pegs for screw fixation into the tibia
Detailed Description:
Around 4 of total knee arthroplasties TKA are revised 15 years after the primary operation most due to loosening of the implant The use of uncemented prostheses are expected to extend the fixation time and thereby the years of TKA survival When a cementless implant is inserted direct bone ingrowth to the implant depends on a complete primary stabilisation Movement between the bone and implant will cause a fibrous membrane leading to micromotions Micromotions can be evaluated by radiophotogrammetric analysis RSA in early follow-up and they have been shown to be a prognostic marker for painful loosening of the implant
Tantalum is a fairly new biomaterial designed with a high and bone-binding porosity Tantalum has already proven to be a good prosthesis material facilitating fast bone-ingrowth and supplying mechanical qualities in the bone-prosthesis interface that surpasses the qualities of regular prosthesis materials by uncemented method Titanium on the other hand has been used as a prosthesis coating for years and also promote prosthesis fixation by osteointegration
The purpose of this study is to compare the early migration of two uncemented total knee implants with different metal coating and fixation method Only the tibial prosthesis plateau varies in design One plateau is a 2 pegged tantalum monobloc and the other plateau is a modular titanium fiber-mesh coating with 4 short pegs for screw fixation into the tibia
Furthermore the extend of the expected micromovements between the polyethylene liner and the metal backing of the titanium plateau will be compared to the stable tantalum monobloc
Theoretically tantalum should allow a more optimal coating for bone ingrowth but as primary stability is also important for longterm prostheses survival the method of primary fixation could alså play a role
To evaluate both the plateau-bone micromotions and the polyethylene-prosthesis micromovements metal markers have been placed on the prosthesis pre-operatively and furthermore into the tibial bone and into the tibial polyethylene during surgery allowing us to evaluate stereo x-rays by a photogrammetric 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 2 years and 5 years post-surgery
Tantalum is a fairly new biomaterial designed with a high and bone-binding porosity Tantalum has already proven to be a good prosthesis material facilitating fast bone-ingrowth and supplying mechanical qualities in the bone-prosthesis interface that surpasses the qualities of regular prosthesis materials by uncemented method Titanium on the other hand has been used as a prosthesis coating for years and also promote prosthesis fixation by osteointegration
The purpose of this study is to compare the early migration of two uncemented total knee implants with different metal coating and fixation method Only the tibial prosthesis plateau varies in design One plateau is a 2 pegged tantalum monobloc and the other plateau is a modular titanium fiber-mesh coating with 4 short pegs for screw fixation into the tibia
Furthermore the extend of the expected micromovements between the polyethylene liner and the metal backing of the titanium plateau will be compared to the stable tantalum monobloc
Theoretically tantalum should allow a more optimal coating for bone ingrowth but as primary stability is also important for longterm prostheses survival the method of primary fixation could alså play a role
To evaluate both the plateau-bone micromotions and the polyethylene-prosthesis micromovements metal markers have been placed on the prosthesis pre-operatively and furthermore into the tibial bone and into the tibial polyethylene during surgery allowing us to evaluate stereo x-rays by a photogrammetric 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 2 years and 5 years post-surgery
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