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

NCT01290640 | Completed Results

• 2 other identifiers: Komistek AG 08-19-20R011373360
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

The objectives of this study are four-fold:

1. 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. 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. 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. 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

Outcome Measures

Primary Outcomes (2)

• In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.

  The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.

  March 2013

• In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.

  Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative.

  March 2013

Study Arms (2)

TC3 TKA

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

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

PFC RP TC3 TKA

Subjects implanted with a DePuy PFC Rotating Platform TC3 TKA

Device: DePuy PFC Rotating Platform TC3 TKA

Interventions

DePuy fixed-bearing Total Condylar III (TC3) TKA DEVICE

TC3 TKA

DePuy PFC Rotating Platform TC3 TKA DEVICE

PFC RP TC3 TKA

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects requiring total knee arthroplasty

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.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• DePuy Orthopaedics: collaborator

Study Sites (3)

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Perkins Hall

Knoxville, Tennessee, 37996, United States

Location

Science and Engineering Research Facility

Knoxville, Tennessee, 37996, United States

Location

Limitations and Caveats

No limitations were encountered.

Results Point of Contact

• Title: Dr. Richard Komistek, Professor
• Organization: The University of Tennessee

rkomiste@utk.edu

865-974-4159

Study Officials

• Richard D. Komistek, Ph D

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

• Douglas Dennis, MD

  Colorado Joint Replacement, Porter Adventist Hosp

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 7, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: February 1, 2013
• Last Updated: October 21, 2019
• Results First Posted: March 7, 2014

Record last verified: 2019-10

Locations

US (3)