Evaluation of Patellar Crepitus Following Total Knee Arthroplasty

Total Knee Replacement Clinical Trial

Official title:

Evaluation of Patellar Crepitus Following PFC Sigma vs. PFC Sigma HP Total Knee Arthroplasty: Does Femoral Component Design Make a Difference?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340144
• Other study ID #: IIS-000112
• Status: Completed
• Phase: N/A
• First received: April 20, 2011
• Last updated: March 4, 2015
• Start date: April 2011
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Colorado Joint Replacement
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• subjects that received primary total knee replacement

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Total Knee Replacement

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Colorado Joint Replacement	DePuy Orthopaedics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (Total Knee Arthroplasty) Procedure in Each Subject.	The incidence of patellar crepitus and clunk will be statistically compared between the study (PFC Sigma HP PS TKA) and control (PFC Sigma PS TKA groups). Based on a strength analysis to determine a theoretical reduction in the incidence of patellar crepitus from 5% to 2%, a study group of 625 subjects in both the control and study ggroups will be required. Each group will also be statistically analyzed using the following variables: overall crepitus incidence, incidence of crepitus requiring only non-operative treatment vs. those requiring operative treatment to manage this complication.	Two years after TKA (Total Knee Arthroplasty) procedure	No