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Evaluation of Patellar Crepitus Following Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01340144
Recruitment Status : Completed
First Posted : April 22, 2011
Results First Posted : March 5, 2015
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
Colorado Joint Replacement

Study Description
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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%.

Condition or disease
Total Knee Replacement

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.
Study Design
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Study Type : Observational
Actual Enrollment : 1250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Patellar Crepitus Following PFC Sigma vs. PFC Sigma HP Total Knee Arthroplasty: Does Femoral Component Design Make a Difference?
Study Start Date : April 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Groups and Cohorts
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Group/Cohort
PFC Sigma PS TKA
one group received primary TKA using the PFC Sigma PS TKA
PFC Sigma HP PS TKA
One group received primary TKA using the PFC Sigma HP PS TKA.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Colorado Joint replacement clinic
Criteria

Inclusion Criteria:

  • subjects that received primary total knee replacement

Exclusion Criteria:

  • Did not return for follow - up appointments Required any post operative manipulation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340144


Sponsors and Collaborators
Colorado Joint Replacement
DePuy Orthopaedics
Investigators
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Principal Investigator: Raymond Kim, MD Porter Adventist Hospital
More Information
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Responsible Party: Colorado Joint Replacement
ClinicalTrials.gov Identifier: NCT01340144    
Other Study ID Numbers: IIS-000112
First Posted: April 22, 2011    Key Record Dates
Results First Posted: March 5, 2015
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Colorado Joint Replacement:
total knee replacement
patellar crepitus
Replacement of knee joint