Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279838
Status:
COMPLETED
Last Update Posted:
2011-03-23
First Post:
2006-01-18
Brief Title:
Computer Assisted Total Knee Replacement
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Computer Assisted Navigation in Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2011-03
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:
The purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in Total Knee Arthroplasty TKA
Detailed Description:
Primary data to be obtained is to determine whether mechanical axis of the limb malignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation
Three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including full length standing standard AP weight bearing lateral patellar kneelingfilm views and CT evaluation In addition a correlation betweeen the CT measures and the kneeling x-ray can be performed at this time Clinical Knee Scale Society WOMAC and SF-36 data will also be obtained at the three month interval
Three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including full length standing standard AP weight bearing lateral patellar kneelingfilm views and CT evaluation In addition a correlation betweeen the CT measures and the kneeling x-ray can be performed at this time Clinical Knee Scale Society WOMAC and SF-36 data will also be obtained at the three month interval
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