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Patellar InstabilityNCT02998372

Computational Simulation of Patellar Instability

An observational study of Patellar Instability, run by Cleveland Clinic Akron General at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages Up to 89 yearsHealthy volunteers can take part
Conditions the study is for
Patellar Instability
What is being tested?
patellar stabilization
Type of treatment
Surgery or procedure
How many people
3 participants
Where
1 siteUnited States
Study dates
30 May 2017to 31 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Akron Children's Hospital

    Akron, Ohio, 44308-1046

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
patellar stabilization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • patellar stabilizationProcedure or surgery

    surgery to either alter soft tissues around the patella or reorient the patellar tendon to restore patellar stability

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Graphical representation of changes in knee motion due to surgery

    Computational models will be developed from MRI scans to show pre-operative and post-operative motion patterns for knees with instability

    Measured: 16 months

  2. Computational simulation of changes in knee motion due to surgery

    The models used to display motion will be converted to dynamic simulation models to predict the influence of multiple surgical approaches on knee motion

    Measured: 24 months

Secondary outcomes (1)

  1. Influence of anatomy on surgical effectiveness

    The simulation models will be used to relate the effectiveness of each procedure to the anatomy of the knees

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2016 (estimated)
  2. Study start30 May 2017
  3. Primary completion31 Jan 2019
  4. Study completion31 Jan 2019

Why it stopped: Not reaching targeted enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02998372
Sponsor's protocol ID
110908
Status last verified
May 2019
First submitted
16 Dec 2016
Last updated
28 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Elias JJ, Cosgarea AJ. Technical errors during medial patellofemoral ligament reconstruction could overload medial patellofemoral cartilage: a computational analysis. Am J Sports Med. 2006 Sep;34(9):1478-85. doi: 10.1177/0363546506287486. Epub 2006 May 9.

    PubMed 16685097

  • Biyani R, Elias JJ, Saranathan A, Feng H, Guseila LM, Morscher MA, Jones KC. Anatomical factors influencing patellar tracking in the unstable patellofemoral joint. Knee Surg Sports Traumatol Arthrosc. 2014 Oct;22(10):2334-41. doi: 10.1007/s00167-014-3195-y. Epub 2014 Jul 26.

    PubMed 25063490

  • Elias JJ, Carrino JA, Saranathan A, Guseila LM, Tanaka MJ, Cosgarea AJ. Variations in kinematics and function following patellar stabilization including tibial tuberosity realignment. Knee Surg Sports Traumatol Arthrosc. 2014 Oct;22(10):2350-6. doi: 10.1007/s00167-014-2905-9. Epub 2014 Feb 15.

    PubMed 24531362

  • Purevsuren T, Elias JJ, Kim K, Kim YH. Dynamic simulation of tibial tuberosity realignment: model evaluation. Comput Methods Biomech Biomed Engin. 2015;18(14):1606-10. doi: 10.1080/10255842.2014.936857. Epub 2014 Jul 15.

    PubMed 25025488

  • Fitzpatrick CK, Steensen RN, Tumuluri A, Trinh T, Bentley J, Rullkoetter PJ. Computational analysis of factors contributing to patellar dislocation. J Orthop Res. 2016 Mar;34(3):444-53. doi: 10.1002/jor.23041. Epub 2015 Sep 15.

    PubMed 26331373

  • Elias JJ, Saranathan A. Discrete element analysis for characterizing the patellofemoral pressure distribution: model evaluation. J Biomech Eng. 2013 Aug;135(8):81011. doi: 10.1115/1.4024287.

    PubMed 23719962

  • Guess TM, Liu H, Bhashyam S, Thiagarajan G. A multibody knee model with discrete cartilage prediction of tibio-femoral contact mechanics. Comput Methods Biomech Biomed Engin. 2013;16(3):256-70. doi: 10.1080/10255842.2011.617004. Epub 2011 Oct 4.

    PubMed 21970765

  • Guess TM, Thiagarajan G, Kia M, Mishra M. A subject specific multibody model of the knee with menisci. Med Eng Phys. 2010 Jun;32(5):505-15. doi: 10.1016/j.medengphy.2010.02.020. Epub 2010 Mar 31.

    PubMed 20359933

  • Elias JJ, Kelly MJ, Smith KE, Gall KA, Farr J. Dynamic Simulation of the Effects of Graft Fixation Errors During Medial Patellofemoral Ligament Reconstruction. Orthop J Sports Med. 2016 Sep 20;4(9):2325967116665080. doi: 10.1177/2325967116665080. eCollection 2016 Sep.

    PubMed 27709116

  • Elias JJ, Soehnlen NT, Guseila LM, Cosgarea AJ. Dynamic tracking influenced by anatomy in patellar instability. Knee. 2016 Jun;23(3):450-5. doi: 10.1016/j.knee.2016.01.021. Epub 2016 Feb 26.

    PubMed 26922799

Questions about this trial

What is this clinical trial studying?

An observational study of Patellar Instability, run by Cleveland Clinic Akron General at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Not reaching targeted enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Graphical representation of changes in knee motion due to surgery (time frame: 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02998372, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.

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