Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-25 @ 1:36 PM
Study NCT ID:
NCT01714492
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2012-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
Sponsor:
The University of Tennessee, Knoxville
Organization:
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 cam/post 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 cam/post 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 cam/post 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 cam/post 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 cam/post 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 cam/post contact mechanics under in vivo conditions.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01 1373 424 | OTHER | The University of Tennessee | View |