Assessment of the Risk of Contralateral Non Simultaneous Neck of Femur Fracture in the Elderly.

Neck of Femur Fracture Clinical Trial

Official title:

Assessment of the Risk of Contralateral Non Simultaneous Neck of Femur Fracture in the Elderly. CT Based Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02577081
• Other study ID #: 0163-15-MMC
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2015
• Last updated: September 17, 2016
• Start date: January 2016
• Est. completion date: October 2020

Study information

• Verified date: September 2016
• Source: Meir Medical Center
• Contact: Niv Marom, M.D
• Phone: +972-52-2228627
• Email: niv.marom[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Neck of femur fractures are common in the elderly and are the source of significant morbidity and mortality. This study is based on a new technique developed in Ben Gurion University, with which investigators are able to asses the structural 3 dimensional strength of a bone by applying a unique simulation on a CAT scan of the bone. The purpose of this study is to evaluate the risk of a contralateral neck of femur fracture after the first neck of femur fracture and to estimate the potential fracture characteristics.

Description:

Neck of femur fractures are common in the elderly and are the source of significant morbidity and mortality. literature shows that around 10 percent of those who fracture their femoral neck for the first time will later fracture their contralateral neck of femur and in most cases with the same fracture characteristics. This study is based on a new technique developed in Ben Gurion University, with which investigators are able to asses the structural 3 dimensional strength of a bone by applying a unique simulation on a CAT scan of the bone. The purpose of this study is to evaluate the risk of a contralateral neck of femur fracture after the first neck of femur fracture and to estimate the potential fracture characteristics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2020
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 90 Years

Eligibility

Inclusion Criteria:

• 70-90 years old patients admitted to the orthopaedic department after neck of femur fracture.

• No contra lateral femur pathology.

• Consent for pelvis and femurs CAT scan.

Exclusion Criteria:

• Known pathology in other lower limbs joints in the body.

• History of previous fractures or operations in lower limbs.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Femoral Fractures
• Femoral Neck Fractures
• Fractures, Bone
• Neck of Femur Fracture

Intervention

Other:
• CAT scan (CT scan)
all patients will pass a CAT scan of ths pelvis and the 2 femurs. No other interventions are required.

Locations

Country	Name	City	State
Israel	Meir medical center	Kfar Saba

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

References & Publications (5)

Burgers PT, Zielinski SM, Mailuhu AK, Heetveld MJ, Verhofstad MH, Roukema GR, Patka P, Poolman RW, Van Lieshout EM; Dutch femoral neck fracture investigator group. Cumulative incidence and treatment of non-simultaneous bilateral femoral neck fractures in a cohort of one thousand two hundred and fifty patients. Int Orthop. 2014 Nov;38(11):2335-42. doi: 10.1007/s00264-014-2447-2. Epub 2014 Aug 3. — View Citation

Gaumetou E, Zilber S, Hernigou P. Non-simultaneous bilateral hip fracture: epidemiologic study of 241 hip fractures. Orthop Traumatol Surg Res. 2011 Feb;97(1):22-7. doi: 10.1016/j.otsr.2010.07.011. Epub 2011 Jan 15. — View Citation

Trabelsi N, Yosibash Z, Wutte C, Augat P, Eberle S. Patient-specific finite element analysis of the human femur--a double-blinded biomechanical validation. J Biomech. 2011 Jun 3;44(9):1666-72. doi: 10.1016/j.jbiomech.2011.03.024. Epub 2011 Apr 15. Erratum in: J Biomech. 2012 Feb 23;45(4):724-5. — View Citation

Yosibash Z, Tal D, Trabelsi N. Predicting the yield of the proximal femur using high-order finite-element analysis with inhomogeneous orthotropic material properties. Philos Trans A Math Phys Eng Sci. 2010 Jun 13;368(1920):2707-23. doi: 10.1098/rsta.2010.0074. — View Citation

Yosibash Z, Trabelsi N, Milgrom C. Reliable simulations of the human proximal femur by high-order finite element analysis validated by experimental observations. J Biomech. 2007;40(16):3688-99. Epub 2007 Aug 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The risk of a contralateral neck of femur fracture	A patient specific analysis based on CT scan and finite element analysis will be done on both neck of femurs.	5 years	No
Secondary	3 dimensional charataristics of the neck of femur fracture	The CAT scan will provide 3 dimensional characteristics of the current neck of femur fracture as well as the predicted one in the contralateral femur. The fracture will be described using orthopaedic classifications, such as: garden classification for neck of femur fractures and AO classification for intertrochanteric fractures of the femur.	1 year	No