Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA

Completed

Conditions studied: Knee Prosthesis, Knee Replacement Arthroplasty

In brief

Utilize previously developed mathematical model to determine in vivo knee mechanics (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA will experience polyethylene bearing rotation at 10 years post-operative, similar to their previous evaluations at six months, two years and five years.

Key facts

Study ID

NCT01714492

Run by

The University of Tennessee, Knoxville

People needed

8

Starts

2012-04-01

Expected to finish

2012-11-01

Last updated by the study team

2019-10-10

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least six months post-operative
• Between 40-85 years of age
• Have a body weight of less than 250 lbs.
• Judged clinically successful with a AKS greater than 90
• Have the DePuy Sigma mobile bearing TKA
• Good-to-excellent post-operative passive flexion
• Must be willing to sign the IC and HIPAA forms.

You may not qualify if…

• Pregnant females
• Those not willing to sign the IC and HIPAA forms

Where it is running

• Porter Adventist Hospital, Colorado Joint Replacement — Denver, Colorado, United States
• Perkins Hall, The University of Tennessee — Knoxville, Tennessee, United States
• Science and Engineering Research Facility, The University of Tennessee — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.