NCT01714492

Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA

In Vivo Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: The University of Tennessee, Knoxville · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Additional hypotheses: * Subjects having a Sigma RP PS TKA will experience full ideal femorotibial contact mechanics. * Subjects having a Sigma RP PS TKA will experience optimal cam/post mechanics. * Subjects having a Sigma RP PS TKA will experience continuous axial rotation in deep flexion. * Subjects having a Sigma RP PS TKA will experience optimal distribution of tibio-femoral and cam/post contact forces over a broad area on the post. * Subjects having a Sigma RP PS TKA will experience a smooth transition of the cam on the post, not an abrupt slide as seen with fixed bearing PS TKA. * The use of the sound sensors will detect cam/post contact mechanics under in vivo conditions.

Conditions

• Knee Prosthesis
• Knee Replacement Arthroplasty

Interventions

Type	Name	Description
DEVICE	Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly	Sigma PS RP TKA including a polyethylene insert with 4 beads

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-10-26
• Last updated: 2019-10-10
• Results posted: 2014-02-17

Locations

3 sites across 1 country: United States