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Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis

NCT01290640 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2019-10-21

Study results available
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Summary

The objectives of this study are four-fold:

1. To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing the in vivo kinematics to determine if one implant type leads to a benefit for the patient.
2. To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar III Prosthesis under in vivo, weight-bearing conditions during multiple activities (gait, stair descent, deep knee bend and chair rise).
3. To determine if there is a correlation between in vivo kinematic data obtained using fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine if variability occurs between these two TKA types.
4. To determine if a clinical benefit is either visibly detected (video camera) or quantifiably determined (questionnaire) for either TKA type.

Conditions

  • Knee Prosthesis
  • Knee Arthroplasty

Interventions

DEVICE

DePuy fixed-bearing Total Condylar III (TC3) TKA

DEVICE

DePuy PFC Rotating Platform TC3 TKA

Sponsors & Collaborators

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • The University of Tennessee, Knoxville

    lead OTHER

Principal Investigators

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

  • Douglas Dennis, MD · Colorado Joint Replacement, Porter Adventist Hosp

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-09-30
Completion
2013-02-28

Countries

  • United States

Study Locations

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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 NCT01290640 on ClinicalTrials.gov