Evaluation of Patellar Crepitus Following Total Knee Arthroplasty

Colorado Joint Replacement

Status: Completed

Conditions: Total Knee Replacement

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01340144

IIS-000112

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 1,250 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects that received primary total knee replacement

Exclusion criteria

• Did not return for follow - up appointments Required any post operative manipulation

Trial design

1,250 participants in 2 patient groups

PFC Sigma PS TKA

Description:

one group received primary TKA using the PFC Sigma PS TKA

PFC Sigma HP PS TKA

Description:

One group received primary TKA using the PFC Sigma HP PS TKA.