CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Sigma Posterior Stabilizing Rotating Platform TKA Beaded Polydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01714492
NCT01714492N/ACompleted
CompareCT.gov

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

The University of Tennessee, Knoxville·observational·Posted Oct 26, 2012·Updated Oct 10, 2019

In Brief

An observational study evaluating Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly for Knee Prosthesis and Knee Replacement Arthroplasty. Completed, enrolled 8 participants across 3 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Prosthesis, Knee Replacement Arthroplasty
CountriesUnited States
CollaboratorsDePuy Orthopaedics

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 26, 2012
Enrollment StartApr 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.7 years ago

Interventions

Sigma Posterior Stabilizing Rotating Platform TKA Beaded Polydevice

Sigma PS RP TKA including a polyethylene insert with 4 beads