In Vivo Determination of 3D Patellofemoral Mechanics (Patella)

October 17, 2019 updated by: Richard Komistek, The University of Tennessee, Knoxville
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80210
        • Colorado Joint Replacement
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • Perkins Hall
      • Knoxville, Tennessee, United States, 37996
        • Science and Engineering Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Full extension to maximum flexion. Degrees of flexion analyzed for participants with and without implants.
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
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.
Patellar rotation from full extension to maximum flexion for subjects with and without implants. 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.
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
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.
full extension to maximum flexion for participants with and without implants.
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
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.
full extension to maximum flexion for participants with and without implants. 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
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
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.
full extension to maximum flexion for participants with and without implants. Position of patellar contact point was determined by locating closest point to femur on patella throughout flexion. There are 2 patello-femoral contact points: 1 point on the medial aspect of the patella and 1 point on the lateral aspect of the patella. Throughout flexion, 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. 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)."
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Tennessee, Knoxville

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
DePuy Orthopaedics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard D. Komistek, Ph D, The University of Tennessee
  • Principal Investigator: Douglas Dennis, MD, Colorado Joint Replacement, Porter Adventist Hosp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10035/IIS-000126
  • R011373372 (Other Grant/Funding Number: DePuy Orthopaedics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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