Evaluation of Patellar Crepitus Following Total Knee Arthroplasty

NCT01340144 | Completed Results

• 1 other identifier: IIS-000112
• Study Type: observational
• Target: 1,250
• Locations: 0 countries
• Sites: N/A

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%.

Conditions

Total Knee Replacement

Keywords

total knee replacement; patellar crepitus; Replacement of knee joint

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Colorado Joint replacement clinic

You may qualify if:

• subjects that received primary total knee replacement

You may not qualify if:

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

Sponsors & Collaborators

• Colorado Joint Replacement: lead
• DePuy Orthopaedics: collaborator

Results Point of Contact

• Title: Raymond Kim, MD
• Organization: Colorado Joint Replacement

raymondkim@ccentura.org

720-524-1367

Study Officials

• Raymond Kim, MD

  Porter Adventist Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 22, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 25, 2015
• Results First Posted: March 5, 2015

Record last verified: 2015-03