Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597684
Status:
TERMINATED
Last Update Posted:
2022-04-08
First Post:
2020-10-09
Brief Title:
Cemented vs Cementless TKA
Sponsor:
OrthoCarolina Research Institute Inc
Organization:
OrthoCarolina Research Institute Inc
Study Overview
Official Title:
What Are the Results of Cemented vs Cementless TKA With the Same Implant Design A Randomized Clinical Trial
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment volume below acceptable accrual rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators are evaluating an implant Depuy Attune TKA that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant
Detailed Description:
Aseptic Loosening remains a leading cause for revision following TKA Cemented TKAs have shown high failure rates in obese and younger populations There is renewed interest in biologic fixation of total knee components with a more active and younger patient population as well as long term alternatives in obese patients receiving TKA
Questions remain whether cemented or cementless long term fixation is superior in total knee arthroplasty in these populations
Potential benefits of cementless fixation include preservation of bone decreased operative times and elimination of complications specific to cemented components Older cementless TKA designs had higher failure rates due to poor fixation methods patch porous coating on the implant poor tibial locking mechanisms and the use of conventional polyethylene The combination of these factors led to unacceptable failure rates in these devices Newer designs have looked to improve these flaws with advances in the biologic interface use of highly porous metals improved locking mechanisms and cross-linked polyethylene
Recently cementless implants with these improved design features have shown improved long term outcomes of cementless components versus their cemented predecessors The combination of these improved long term outcomes in younger more active population warrant further investigation of cementless components in TKA There is a need for more durable long term fixation in all implants treating obese as well as young active patients
The investigators are evaluating an implant Depuy Attune TKA that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant
Questions remain whether cemented or cementless long term fixation is superior in total knee arthroplasty in these populations
Potential benefits of cementless fixation include preservation of bone decreased operative times and elimination of complications specific to cemented components Older cementless TKA designs had higher failure rates due to poor fixation methods patch porous coating on the implant poor tibial locking mechanisms and the use of conventional polyethylene The combination of these factors led to unacceptable failure rates in these devices Newer designs have looked to improve these flaws with advances in the biologic interface use of highly porous metals improved locking mechanisms and cross-linked polyethylene
Recently cementless implants with these improved design features have shown improved long term outcomes of cementless components versus their cemented predecessors The combination of these improved long term outcomes in younger more active population warrant further investigation of cementless components in TKA There is a need for more durable long term fixation in all implants treating obese as well as young active patients
The investigators are evaluating an implant Depuy Attune TKA that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None