MedTrace Logo

Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA

NCT01714492 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2019-10-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Knee Prosthesis
  • Knee Replacement Arthroplasty

Interventions

DEVICE

Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly

Sigma PS RP TKA including a polyethylene insert with 4 beads

Sponsors & Collaborators

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • The University of Tennessee, Knoxville

    lead OTHER

Principal Investigators

  • Richard D Komistek, Ph. D. · The University of Tennessee

  • Dennis A Douglas, MD · Colorado Joint Replacement

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01714492 on ClinicalTrials.gov