Computational Simulation of Patellar Instability

NCT02998372 | Terminated

• 1 other identifier: 110908
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellar Instability

Outcome Measures

Primary Outcomes (2)

• 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

  16 months

• 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

  24 months

Secondary Outcomes (1)

• Influence of anatomy on surgical effectiveness

  24 months

Interventions

patellar stabilization PROCEDURE

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

Eligibility Criteria

• Age: Up to 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cleveland Clinic Akron General: lead
• Akron Children's Hospital: collaborator

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308-1046, United States

Location

Related Publications (10)

• 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.

  PMID: 16685097 BACKGROUND

• 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.

  PMID: 25063490 BACKGROUND

• 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.

  PMID: 24531362 BACKGROUND

• 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.

  PMID: 25025488 BACKGROUND

• 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.

  PMID: 26331373 BACKGROUND

• 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.

  PMID: 23719962 BACKGROUND

• 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.

  PMID: 21970765 BACKGROUND

• 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.

  PMID: 20359933 BACKGROUND

• 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.

  PMID: 27709116 BACKGROUND

• 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.

  PMID: 26922799 BACKGROUND

Study Officials

• John Elias, PhD

  Cleveland Clinic Akron General

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: May 30, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)