NCT02577081

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

September 24, 2015

Last Update Submit

September 17, 2016

Conditions

Neck of Femur Fracture

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 3 dimensional charataristics of the neck of femur fracture

    1 year

Study Arms (1)

CAT scan

EXPERIMENTAL

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

Other: CAT scan (CT scan)

Interventions

CAT scan (CT scan)OTHER

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

CAT scan

Eligibility Criteria

Age70 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known pathology in other lower limbs joints in the body.
  • History of previous fractures or operations in lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir medical center

Kfar Saba, 44538, Israel

RECRUITING

Related Publications (5)

  • 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.

    PMID: 21239241BACKGROUND

  • 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.

    PMID: 25086819BACKGROUND

  • 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.

    PMID: 17706228BACKGROUND

  • 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.

    PMID: 20439270BACKGROUND

  • 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.

    PMID: 21497354BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • niv marom, MD

    meir medical cenrter

    STUDY CHAIR

Central Study Contacts

Niv Marom, M.D

CONTACT

+972-52-2228627niv.marom@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Niv marom, Resident, Department of Orthopaedic surgery

Study Record Dates

First Submitted

September 24, 2015

First Posted

October 16, 2015

Study Start

January 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2020

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)