Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis
Completed
Conditions studied: Knee Prosthesis, Knee Arthroplasty
In brief
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.
Key facts
- Study ID
- NCT01290640
- Run by
- The University of Tennessee, Knoxville
- People needed
- 22
- Starts
- 2011-02-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2019-10-21
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be at least three months post-operative.
- Potential subjects will have a body weight of less than 250 lbs.
- Candidates must have had a HSS score >90 post-operatively.
- Patients must have passive flexion of at least 100.
- All potential subjects will have a Press Fit Condylar (PFC) Rotating Platform Total Condylar III Prosthesis (Depuy Orthopaedics, Warsaw, IN) or fixed-bearing Total Condylar III Prosthesis.
- Must be willing to sign both Informed Consent and HIPAA forms.
You may not qualify if…
- Pregnant females.
- Patients that do not meet study requirements.
Where it is running
- Porter Adventist Hospital — Denver, Colorado, United States
- Perkins Hall — Knoxville, Tennessee, United States
- Science and Engineering Research Facility — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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