Evaluation of Patellar Crepitus Following Total Knee Arthroplasty

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%.

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Key information

Conditions

Total Knee Replacement

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

subjects that received primary total knee replacement

Exclusion criteria

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

Treatment and study plan

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 (Total Knee Arthroplasty) Procedure in Each Subject.

Time frame: Two years after TKA (Total Knee Arthroplasty) procedure

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.

Sponsors and collaborators

Lead sponsor

Colorado Joint Replacement

Other

Collaborators

DePuy Orthopaedics

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Apr 22, 2011
Registry last updated: Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed