Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01340144
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2011-04-20
Brief Title:
Evaluation of Patellar Crepitus Following Total Knee Arthroplasty
Sponsor:
Colorado Joint Replacement
Organization:
Colorado Joint Replacement
Study Overview
Official Title:
Evaluation of Patellar Crepitus Following PFC Sigma vs PFC Sigma HP Total Knee Arthroplasty Does Femoral Component Design Make a Difference
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Analyze clinical data for a group of subjects implanted with a new surgical device designed to reduce the incidence of patellar crepitus following PCL-substituting TKA and compare that to a control group of subjects implanted with a TKA design known to have an incidence of patellar crepitus of approximately 5
Detailed Description:
Patellar crepitus and clunk following posterior cruciate substituting total knee arthroplasty is a persistent problem with a reported incidence as high as 14 The development of this complication necessitates additional surgery in some patients Numerous etiologies have been reported including design of the femoral component Due to a higher than desired incidence of patellar crepitus with the PFC Sigma PS TKA design modifications of the trochlear groove of the femoral component were introduced with the release of the PFC Sigma HP PS femoral component The purpose of the proposed study is to evaluate the incidence of patellar crepitus after posterior cruciate substituting TKA utilizing the PFC Sigma vs the PFC Sigma HP PS femoral components
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