In Vivo Determination of 3D Patellofemoral Mechanics (Patella)

This study has been completed.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
Brenda Lawson, The University of Tennessee Knoxville
ClinicalTrials.gov Identifier:
NCT01290627
First received: February 3, 2011
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Arthroplasty Replacement Knee
Knee Prosthesis
Device: Subjects implanted with DePuy LCS PS RP TKA
Device: Subjects implanted with DePuy Sigma PS RP TKA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: In Vivo Determination of 3D Patellofemoral Mechanics

Resource links provided by NLM:


Further study details as provided by The University of Tennessee Knoxville:

Primary Outcome Measures:
  • Patella Flexion With Respect to Femur [ Time Frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. ] [ Designated as safety issue: No ]
    Full extension to maximum flexion.

  • Patella Rotation With Respect to Femur [ Time Frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. ] [ Designated as safety issue: No ]
    Patellar rotation from full extension to maximum flexion. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.

  • Patella Tilt With Respect to Femur [ Time Frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. ] [ Designated as safety issue: No ]
    full extension to maximum flexion

  • Normalized Medial Patella Contact Point Translation [ Time Frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. ] [ Designated as safety issue: No ]
    full extension to maximum flexion. The position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."

  • Normalized Lateral Patella Contact Point Translation [ Time Frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. ] [ Designated as safety issue: No ]
    full extension to maximum flexion. The position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."


Enrollment: 30
Study Start Date: February 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Knee Prosthesis LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Device: Subjects implanted with DePuy LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Knee Prosthesis Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Device: Subjects implanted with DePuy Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Control
Subjects with normal knees

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290627

Locations
United States, Colorado
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Colorado Joint Replacement
Denver, Colorado, United States, 80210
United States, Tennessee
Science and Engineering Research Facility
Knoxville, Tennessee, United States, 37996
Perkins Hall
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
The University of Tennessee Knoxville
DePuy Orthopaedics
Investigators
Principal Investigator: Richard D. Komistek, Ph D The University of Tennessee
Principal Investigator: Douglas Dennis, MD Colorado Joint Replacement, Porter Adventist Hosp
  More Information

No publications provided

Responsible Party: Brenda Lawson, Compliance Officer, The University of Tennessee Knoxville
ClinicalTrials.gov Identifier: NCT01290627     History of Changes
Other Study ID Numbers: 10035/IIS-000126, R011373372
Study First Received: February 3, 2011
Results First Received: May 17, 2013
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 23, 2014