Patellar Instability Clinical Trial
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
NCT number | NCT02998372 |
Other study ID # | 110908 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | May 30, 2017 |
Est. completion date | January 31, 2019 |
Verified date | May 2019 |
Source | Akron General Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 89 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Akron Children's Hospital | Akron | Ohio |
Lead Sponsor | Collaborator |
---|---|
Akron General Medical Center | Akron Children's Hospital |
United States,
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. — View Citation
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. — View Citation
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. Epub 2006 May 9. — View Citation
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. eCollection 2016 Sep. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | 24 months |
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