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

NCT ID: NCT02577081

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-10-31

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.

Conditions

Neck of Femur Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CAT scan

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

Group Type: EXPERIMENTAL

CAT scan (CT scan)

Intervention Type: OTHER

all patients will pass a CAT scan of ths pelvis and the 2 femurs. No other interventions are required.

Interventions

CAT scan (CT scan)

all patients will pass a CAT scan of ths pelvis and the 2 femurs. No other interventions are required.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ben-Gurion University of the Negev

OTHER

Sponsor Role: collaborator

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

niv marom

Niv marom, Resident, Department of Orthopaedic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

niv marom, MD

Role: STUDY_CHAIR

meir medical cenrter

Locations

Meir medical center

Kfar Saba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Niv Marom, M.D

Role: CONTACT

niv.marom@gmail.com

+972-52-2228627

Facility Contacts

Niv Marom, MD

Role: primary

niv.marom@gmail.com

+972-9-7471888

References

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.

Reference Type: BACKGROUND

PMID: 21239241 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25086819 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17706228 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20439270 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21497354 (View on PubMed)

Other Identifiers

0163-15-MMC

Identifier Type: -

Identifier Source: org_study_id