Computational Simulation of Patellar Instability

May 24, 2019 updated by: John Elias, PhD, Akron General Medical Center

Computational Simulation of Dynamic Motion for Knees With Patellar Instability to Compare MPFL Reconstruction to Tibial Tuberosity Medialization as a Function of Knee Anatomy

Computational simulation will be performed to represent motion of knees with a dislocating kneecap. Common surgical treatment methods will be simulated and anatomical parameters commonly associated with the dislocation will be varied in order to characterize the most appropriate surgical approach as a function of knee anatomy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The two most common stabilization procedures for patients with recurrent patellar instability are reconstruction of the medial patellofemoral ligament (MPFL) and medialization of the tibial tuberosity. MPFL reconstruction has been growing in popularity, due in large part to the technical demands of tibial tuberosity realignment and concerns related to bone healing across the osteotomy. In cases of severe trochlear dysplasia and/or a dramatically lateralized tibial tuberosity, an MPFL graft tensioned according to current standards may not provide sufficient resistance to limit lateral patellar tracking that causes continued instability. Increasing graft tension could overload medial patellofemoral cartilage. The proposed study is based on the hypothesis that the ability of MPFL reconstruction to effectively limit lateral patellar maltracking decreases as trochlear dysplasia and the lateral position of the tibial tuberosity increase. Computational dynamic simulation of knee function will be performed to establish anatomical standards for which tibial tuberosity medicalization is more likely than MPFL reconstruction to limit patellar maltracking without overloading patellofemoral cartilage. The first specific aim is to computationally replicate lateral patellar maltracking and pressure applied to cartilage during function for patients being treated for patellar instability. Multibody dynamics knee models representing patients being treated for recurrent patellar instability will be based on 3D reconstructions from MRI scans. The modeling technique treats the bones and cartilage surfaces as rigid bodies with Hertzian contact determining contact forces and guiding joint motion. Discrete element analysis techniques will be used to characterize contact pressure patterns based on overlap of cartilage surfaces. Models will be individually validated by comparing output to in vivo data. The source of the in vivo data will be computational reconstruction of in vivo function based on motions performed by the patients who provide the imaging data for model development. The second specific aim will be to computationally characterize the influence of surgical stabilization on knee function for individual patients. MPFL reconstruction and tibial tuberosity medialization, each with variations in surgical parameters, will be simulated. The actual surgical procedures performed on the patients will be simulated, with the influence on lateral tracking compared to in vivo results to validate the representation of the surgical procedures. The third specific aim will be to compare surgical options as a function of patellofemoral anatomy. Variations in patellar tracking and pressure applied to cartilage will be compared between MPFL reconstruction and tuberosity medialization. In addition, techniques to parametrically alter trochlear dysplasia and tuberosity lateralization within the models will be developed. Simulations will be performed while varying anatomy to set ranges over which each surgical option can limit patellar maltracking without elevating contact pressures. The modeling system will be available for future studies addressing additional surgical options and anatomical parameters related to patellar instability.

Study Type

Observational

Enrollment (Actual)

3

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
    • Ohio
      • Akron, Ohio, United States, 44308-1046
        • Akron Children's Hospital

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

Ages Eligible for Study

No older than 89 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Anyone with a diagnosis of recurrent patellar dislocation to be surgically treated at Akron Children's Hospital

Description

Inclusion Criteria:

  • Diagnosis of recurrent patellar dislocation
  • Plan to be surgically treated at Akron Children's Hospital

Exclusion Criteria:

  • Additional Injuries unrelated to patellar instability for the knee of interest
  • Implantation of metallic hardware that could cause artifacts within MRI scans
  • Inability to remain still during MRI scans

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graphical representation of changes in knee motion due to surgery
Time Frame: 16 months
Computational models will be developed from MRI scans to show pre-operative and post-operative motion patterns for knees with instability
16 months
Computational simulation of changes in knee motion due to surgery
Time Frame: 24 months
The models used to display motion will be converted to dynamic simulation models to predict the influence of multiple surgical approaches on knee motion
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of anatomy on surgical effectiveness
Time Frame: 24 months
The simulation models will be used to relate the effectiveness of each procedure to the anatomy of the knees
24 months

Collaborators and Investigators

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

Sponsor

Akron General Medical Center

Collaborators

Akron Children's Hospital

Investigators

  • Principal Investigator: John Elias, PhD, Akron General Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

May 30, 2017

Primary Completion (ACTUAL)

January 31, 2019

Study Completion (ACTUAL)

January 31, 2019

Study Registration Dates

First Submitted

December 16, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 110908

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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