Evaluation of Patellar Crepitus
This trial is active, not recruiting.
|Condition||arthroplasty, replacement, knee|
|Sponsor||Colorado Joint Replacement|
|Start date||April 2011|
|End date||June 2013|
|Trial size||1250 participants|
|Trial identifier||NCT01340144, IIS-000112|
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%.
|Observational model||case control|
one group received primary TKA using the PFC Sigma PS TKA
One group received primary TKA using the PFC Sigma HP PS TKA.
Evaluate for the incidence of patellar crepitus requiring non-operative vs. operative treatment of both the study and control groups at a minimum of 12 months following the TKA procedure in each subject.
time frame: one year after TKA procedure
Male or female participants of any age.
Inclusion Criteria: - subjects that received primary total knee replacement Exclusion Criteria: - Did not return for follow - up appointments Required any post operative manipulation
|Official title||Evaluation of Patellar Crepitus Following PFC Sigma vs. PFC Sigma HP Total Knee Arthroplasty: Does Femoral Component Design Make a Difference|
|Principal investigator||Raymond Kim, MD|
|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.|
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