Clinical trial NCT01290627: In Vivo Determination of 3D Patellofemoral Mechanics
Official title: In Vivo Determination of 3D Patellofemoral Mechanics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty Replacement Knee
Knee Prosthesis
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2011-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects recruited from patients chosen from practice of Dr.'s Dennis and Haas at Colorado Joint Replacement for implanted knee, having either one of the two kinds of implants specified.

Brief 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:

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.

Primary outcomes:
measure: Patella Flexion With Respect to Femur
timeFrame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
measure: Patella Rotation With Respect to Femur
timeFrame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
measure: Patella Tilt With Respect to Femur
timeFrame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
measure: Normalized Medial Patella Contact Point Translation
timeFrame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
measure: Normalized Lateral Patella Contact Point Translation
timeFrame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
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: