Computational Simulation of Patellar Instability

NCT ID: NCT02998372

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-30
• Study Completion Date: 2019-01-31

Brief 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 anatomy.

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.

Conditions

Patellar Instability

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

patellar stabilization

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akron Children's Hospital

OTHER

Sponsor Role: collaborator

Cleveland Clinic Akron General

OTHER

Sponsor Role: lead

Responsible Party

John Elias, PhD

Senior Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Elias, PhD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Akron General

Locations

Akron Children's Hospital

Akron, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16685097 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25063490 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24531362 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25025488 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26331373 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23719962 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21970765 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20359933 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27709116 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26922799 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

110908

Identifier Type: -

Identifier Source: org_study_id