Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA

NCT ID: NCT01714492

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-11-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly

subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads

Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly

Intervention Type: DEVICE

Sigma PS RP TKA including a polyethylene insert with 4 beads

Interventions

Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly

Sigma PS RP TKA including a polyethylene insert with 4 beads

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role: lead

Responsible Party

Richard Komistek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard D Komistek, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

The University of Tennessee

Dennis A Douglas, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Joint Replacement

Locations

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

Countries

United States

Other Identifiers

R01 1373 424

Identifier Type: OTHER

Identifier Source: secondary_id

11019

Identifier Type: -

Identifier Source: org_study_id