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%.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
one group received primary TKA using the PFC Sigma PS TKA
One group received primary TKA using the PFC Sigma HP PS TKA.

Primary Outcomes

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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Colorado Joint Replacement.