Evaluation of Patellar Crepitus Following Total Knee Arthroplasty

NCT ID: NCT01340144

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-09-30

Brief 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

Total Knee Replacement

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

PFC Sigma PS TKA

one group received primary TKA using the PFC Sigma PS TKA

No interventions assigned to this group

PFC Sigma HP PS TKA

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• subjects that received primary total knee replacement

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Colorado Joint Replacement

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Porter Adventist Hospital

Other Identifiers

IIS-000112

Identifier Type: -

Identifier Source: org_study_id