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

The University of Tennessee, Knoxville

Status: Completed

Conditions: Knee Arthroplasty; Knee Prosthesis

Treatments: Device: DePuy fixed-bearing Total Condylar III (TC3) TKA; Device: DePuy PFC Rotating Platform TC3 TKA

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01290640

Komistek AG 08-19-20

R011373360 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

22 participants in 2 patient groups

TC3 TKA

Description:

Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA

Treatment:

Device: DePuy fixed-bearing Total Condylar III (TC3) TKA

PFC RP TC3 TKA

Description:

Subjects implanted with a DePuy PFC Rotating Platform TC3 TKA

Treatment:

Device: DePuy PFC Rotating Platform TC3 TKA