In Vivo Determination of 3D Patellofemoral Mechanics (Patella)

The University of Tennessee, Knoxville

Status: Completed

Conditions: Arthroplasty Replacement Knee; Knee Prosthesis

Treatments: Device: Subjects implanted with DePuy LCS PS RP TKA; Device: Subjects implanted with DePuy Sigma PS RP TKA

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01290627

10035/IIS-000126

R011373372 (Other Grant/Funding Number)

Details and patient eligibility

About

This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces) of participants having a normal knee or a total knee arthroplasty (TKA) using one or two different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA). All knees will be analyzed using an image matching technique that will convert a two-dimensional (2D) fluoroscopic image into a three-dimensional (3D) image. In conjunction with the fluoroscopic analysis, electromyography (EMG) data, and ground reaction force (GRF) data will all be allow for a complete analysis of the knee joints. These results will help the orthopaedic community better understand knee motion so they can improve testing on existing implants and develop future implants that will further enhance patients' lives.

Enrollment: 30 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients must be at least six months post-operative.
2. Potential subjects will have a body weight of less than 250 lbs.
3. Candidates must have an AKS score >70 post-operatively.
4. Patients must have passive flexion of at least 100.
5. Implanted group must have either an LCS PS RP TKA, having an anatomical patella, or Sigma PS RP TKA; or normal knee group must have normal knee.
6. Must be willing to sign both Informed Consent and HIPAA forms.

Exclusion criteria

1. Pregnant females.
2. Subjects not meeting study requirements.

Trial design

30 participants in 3 patient groups

Knee Prosthesis LCS PS RP TKA

Description:

Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)

Treatment:

Device: Subjects implanted with DePuy LCS PS RP TKA

Knee Prosthesis Sigma PS RP TKA

Description:

Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)

Treatment:

Device: Subjects implanted with DePuy Sigma PS RP TKA

Control

Description:

Subjects with normal knees