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

Primary Purpose

Neck of Femur Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CAT scan (CT scan)
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neck of Femur Fracture

Eligibility Criteria

70 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Meir medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAT scan

Arm Description

A CAT scan will be done for all participants. The scan will include the pelvis and 2 femurs.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 24, 2015
Last Updated
September 17, 2016
Sponsor
Meir Medical Center
Collaborators
Ben-Gurion University of the Negev
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1. Study Identification

Unique Protocol Identification Number
NCT02577081
Brief Title
Assessment of the Risk of Contralateral Non Simultaneous Neck of Femur Fracture in the Elderly.
Official Title
Assessment of the Risk of Contralateral Non Simultaneous Neck of Femur Fracture in the Elderly. CT Based Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
Collaborators
Ben-Gurion University of the Negev

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck of Femur Fracture

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAT scan
Arm Type
Experimental
Arm Description
A CAT scan will be done for all participants. The scan will include the pelvis and 2 femurs.
Intervention Type
Other
Intervention Name(s)
CAT scan (CT scan)
Intervention Description
all patients will pass a CAT scan of ths pelvis and the 2 femurs. No other interventions are required.
Primary Outcome Measure Information:
Title
The risk of a contralateral neck of femur fracture
Description
A patient specific analysis based on CT scan and finite element analysis will be done on both neck of femurs.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
3 dimensional charataristics of the neck of femur fracture
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niv Marom, M.D
Phone
+972-52-2228627
Email
niv.marom@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
niv marom, MD
Organizational Affiliation
meir medical cenrter
Official's Role
Study Chair
Facility Information:
Facility Name
Meir medical center
City
Kfar Saba
ZIP/Postal Code
44538
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niv Marom, MD
Phone
+972-9-7471888
Email
niv.marom@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21239241
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.
Results Reference
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PubMed Identifier
25086819
Citation
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.
Results Reference
background
PubMed Identifier
17706228
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. doi: 10.1016/j.jbiomech.2007.06.017. Epub 2007 Aug 13.
Results Reference
background
PubMed Identifier
20439270
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.
Results Reference
background
PubMed Identifier
21497354
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.
Results Reference
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Assessment of the Risk of Contralateral Non Simultaneous Neck of Femur Fracture in the Elderly.

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