Clinical Trials Directory

Trials / Completed

CompletedNCT01340144

Evaluation of Patellar Crepitus Following Total Knee Arthroplasty

Evaluation of Patellar Crepitus Following PFC Sigma vs. PFC Sigma HP Total Knee Arthroplasty: Does Femoral Component Design Make a Difference?

Status
Completed
Phase
Study type
Observational
Enrollment
1,250 (actual)
Sponsor
Colorado Joint Replacement · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2011-04-01
Primary completion
2014-06-01
Completion
2014-09-01
First posted
2011-04-22
Last updated
2015-03-25
Results posted
2015-03-05

Source: ClinicalTrials.gov record NCT01340144. Inclusion in this directory is not an endorsement.