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.