Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801654
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2020-12-16
Brief Title:
GMK Sphere TiNb Total Knee Arthroplasty PMS Study
Sponsor:
Medacta International SA
Organization:
Medacta International SA
Study Overview
Official Title:
A Monocentric Prospective Clinical Survey on Long Term Performance of GMK Sphere Total Knee Arthroplasty
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Total knee arthroplasty TKA is one of the success stories of modern surgery providing high patient satisfaction outcomes Total knee prostheses are generally composed by a femoral component articulating on a polyethylene insert and a tibial tray
Recently there has been particular attention on the component material traditionally femoral components are made of cobalt alloys while tibial baseplates are made in the great majority of cases of metallic materials but also polyethylene versions are available There has been a degree of acceptance in some countries that metal related pathology may exist as demonstrated by the Australian Arthroplasty register where metal hypersensitivity was reported as the fifth most common cause for revision hip arthroplasty 2012 report making up for 59 of all revisions The wording was subsequently changed from metal sensitivity to metal related pathology in the 2014 report with 05 of all revision total hip arthroplasties THA associated with this term The same change in terminology was used for TKA with metal sensitivity as a cause for revision in 13 of revisions in 2012 and in 2014 18 of revision TKAs attributed to metal related pathology The overall revision rate was 345 after 10 years in 396472 TKAs suggesting a revision rate of 006-032 secondary to metal or cement allergies Up to today there is no question that metallic implants may generate wear debris that cause local reactions This local reaction is not dose related nor predictable and therefore not purely due to the toxic effect of the debris but possibly due to an immunological host process Hypersensitivity to metal undoubtedly exists but it cannot be stated at the moment to be an allergic reaction To prevent issues arising due to metal related pathology alternative solutions to conventional chrome cobalt material have been proposed for example ceramic component or implant coating In particular TiNbN coating has been proposed by most companies thanks to its excellent biological properties Preclinical studies have showed a high scratch resistance and low coefficient of friction more resistance to fretting corrosion reduction of wear lower ion release rates and low fatigue cycle as described in the review of Hove Clinically cohort of studies of TiN-coated implants showed an overall survival exceeding 90 with a follow-up of 15 to 77 months and good clinical outcomes No reports of adverse effects related to TiN coating of CoCrMo knee implants have been showed There are few studies that compared TiN-coated implants with the same uncoated version Thienpont comparing TiN-coated and uncoated CoCrMo implants showed similar clinical and radiological outcomes at short-term follow up in both patients groups
Overall we can conclude that in literature no adverse events have been reported concerning the TiNbN coating and in particular it has been showed that the coating doesnt not affect the performance of the device if compared with the same uncoated version
The aim of this study is to evaluate the long term clinical and radiological performance of GMK Sphere total knee component coated version
Recently there has been particular attention on the component material traditionally femoral components are made of cobalt alloys while tibial baseplates are made in the great majority of cases of metallic materials but also polyethylene versions are available There has been a degree of acceptance in some countries that metal related pathology may exist as demonstrated by the Australian Arthroplasty register where metal hypersensitivity was reported as the fifth most common cause for revision hip arthroplasty 2012 report making up for 59 of all revisions The wording was subsequently changed from metal sensitivity to metal related pathology in the 2014 report with 05 of all revision total hip arthroplasties THA associated with this term The same change in terminology was used for TKA with metal sensitivity as a cause for revision in 13 of revisions in 2012 and in 2014 18 of revision TKAs attributed to metal related pathology The overall revision rate was 345 after 10 years in 396472 TKAs suggesting a revision rate of 006-032 secondary to metal or cement allergies Up to today there is no question that metallic implants may generate wear debris that cause local reactions This local reaction is not dose related nor predictable and therefore not purely due to the toxic effect of the debris but possibly due to an immunological host process Hypersensitivity to metal undoubtedly exists but it cannot be stated at the moment to be an allergic reaction To prevent issues arising due to metal related pathology alternative solutions to conventional chrome cobalt material have been proposed for example ceramic component or implant coating In particular TiNbN coating has been proposed by most companies thanks to its excellent biological properties Preclinical studies have showed a high scratch resistance and low coefficient of friction more resistance to fretting corrosion reduction of wear lower ion release rates and low fatigue cycle as described in the review of Hove Clinically cohort of studies of TiN-coated implants showed an overall survival exceeding 90 with a follow-up of 15 to 77 months and good clinical outcomes No reports of adverse effects related to TiN coating of CoCrMo knee implants have been showed There are few studies that compared TiN-coated implants with the same uncoated version Thienpont comparing TiN-coated and uncoated CoCrMo implants showed similar clinical and radiological outcomes at short-term follow up in both patients groups
Overall we can conclude that in literature no adverse events have been reported concerning the TiNbN coating and in particular it has been showed that the coating doesnt not affect the performance of the device if compared with the same uncoated version
The aim of this study is to evaluate the long term clinical and radiological performance of GMK Sphere total knee component coated version
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None