Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA

NCT01714492 | Completed Results

• 2 other identifiers: 11019R01 1373 424
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 3

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.

Conditions

Knee Prosthesis; Knee Replacement Arthroplasty

Keywords

Total Knee Arthroplasty (TKA); in vivo mechanics; kinematics; fluoroscopy

Outcome Measures

Primary Outcomes (3)

• In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity

  The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, if the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.

  10 yrs post-operative

• Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity

  10 yrs post-operative

• Range of Motion During Flexion of Deep Knee Bend Activity

  10 yrs post-operative

Secondary Outcomes (3)

• In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity

  10 yrs post-operative

• Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity

  10 yrs post-operative

• Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity

  10 yrs post-operative

Study Arms (1)

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

Device: Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly

Interventions

Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly DEVICE

Sigma PS RP TKA including a polyethylene insert with 4 beads

Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are eight mobile bearing subjects that were implanted over 10 years ago with a custom polyethylene insert that has four beads rigidly inserted into the polyethylene component.

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

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• DePuy Orthopaedics: collaborator

Study Sites (3)

Porter Adventist Hospital, Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Perkins Hall, The University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Science and Engineering Research Facility, The University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Limitations and Caveats

Small study population; only one specific type of mobile bearing implant was analyzed; no definitive way to quantitatively measure level of wear on various implants to determine if there was any influence on the kinematic performance.

Results Point of Contact

• Title: Richard Komistek, Ph. D.
• Organization: The University of Tennessee

rkomiste@utk.edu

8659744159

Study Officials

• Richard D Komistek, Ph. D.

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

• Dennis A Douglas, MD

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 26, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 10, 2019
• Results First Posted: February 17, 2014

Record last verified: 2019-10

Locations

US (3)