Clinical trial NCT01290640: Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis
Official title: In Vivo Comparison of Kinematics for Subjects Implanted With a Press Fit Condylar Sigma Rotating Platform or Fixed Bearing Total Condylar III Prothesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Prosthesis
Knee Arthroplasty
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2011-02-07
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects requiring total knee arthroplasty

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patients must be at least three months post-operative.
2. Potential subjects will have a body weight of less than 250 lbs.
3. Candidates must have had a HSS score \>90 post-operatively.
4. Patients must have passive flexion of at least 100.
5. 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.
6. Must be willing to sign both Informed Consent and HIPAA forms.

Exclusion Criteria:

1. Pregnant females.
2. Patients that do not meet study requirements.

Primary outcomes:
measure: In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.
timeFrame: March 2013
measure: In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.
timeFrame: March 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Porter Adventist Hospital
state: Colorado
city: Knoxville
country: United States
facility: Perkins Hall
state: Tennessee
city: Knoxville
country: United States
facility: Science and Engineering Research Facility
state: Tennessee
Study officials:
affiliation: The University of Tennessee
name: Richard D. Komistek, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado Joint Replacement, Porter Adventist Hosp
name: Douglas Dennis, MD
role: PRINCIPAL_INVESTIGATOR
References: