N/A
N=30
In Vivo Determination of 3D Patellofemoral Mechanics
Arthroplasty Replacement Knee · Knee Prosthesis
Bottom Line
View on ClinicalTrials.gov: NCT01290627 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Patella Flexion With Respect to Femur — 80.0; 83.4; 93.7 degrees
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Subjects implanted with DePuy LCS PS RP TKA (Device); Subjects implanted with DePuy Sigma PS RP TKA (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- The University of Tennessee, Knoxville
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patella Flexion With Respect to Femur |
80.0; 83.4; 93.7 | — |
| PRIMARY Patella Rotation With Respect to Femur |
.5; -.06; -1.6 | — |
| PRIMARY Patella Tilt With Respect to Femur |
4.2; 2.6; 5.3 | — |
| PRIMARY Normalized Medial Patella Contact Point Translation |
.34; .12; .40 | — |
| PRIMARY Normalized Lateral Patella Contact Point Translation |
0.09; .20; .45 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients must be at least six months post-operative.
- Potential subjects will have a body weight of less than 250 lbs.
- Candidates must have an AKS score >70 post-operatively.
- Patients must have passive flexion of at least 100.
- 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.
- Must be willing to sign both Informed Consent and HIPAA forms.
Exclusion Criteria
- Pregnant females.
- Subjects not meeting study requirements.
Data sourced from ClinicalTrials.gov (NCT01290627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.