Ignite Creation Date:
2024-05-06 @ 1:01 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01714492
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2012-10-23
Brief Title:
Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
Sponsor:
The University of Tennessee Knoxville
Organization:
The University of Tennessee Knoxville
Study Overview
Official Title:
In Vivo Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
Status:
COMPLETED
Status Verified Date:
2019-10
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:
Sigma MB TKA
Brief Summary:
Utilize previously developed mathematical model to determine in vivo knee mechanics kinematics forces stresses areas and sound for subjects having a Sigma Posterior Stabilizing PS mobile bearing MB total knee arthroplasty TKA There are several hypotheses for this study although the most prominent is Subjects having a Sigma RP PS TKA will experience polyethylene bearing rotation at 10 years post-operative similar to their previous evaluations at six months two years and five years
Detailed Description:
Additional hypotheses
Subjects having a Sigma RP PS TKA will experience full ideal femorotibial contact mechanics
Subjects having a Sigma RP PS TKA will experience optimal campost mechanics
Subjects having a Sigma RP PS TKA will experience continuous axial rotation in deep flexion
Subjects having a Sigma RP PS TKA will experience optimal distribution of tibio-femoral and campost contact forces over a broad area on the post
Subjects having a Sigma RP PS TKA will experience a smooth transition of the cam on the post not an abrupt slide as seen with fixed bearing PS TKA
The use of the sound sensors will detect campost contact mechanics under in vivo conditions
Subjects having a Sigma RP PS TKA will experience full ideal femorotibial contact mechanics
Subjects having a Sigma RP PS TKA will experience optimal campost mechanics
Subjects having a Sigma RP PS TKA will experience continuous axial rotation in deep flexion
Subjects having a Sigma RP PS TKA will experience optimal distribution of tibio-femoral and campost contact forces over a broad area on the post
Subjects having a Sigma RP PS TKA will experience a smooth transition of the cam on the post not an abrupt slide as seen with fixed bearing PS TKA
The use of the sound sensors will detect campost contact mechanics under in vivo conditions
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01 1373 424 | OTHER | The University of Tennessee | None |